General Information

Clinical Trial is any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s); and/or to identify any adverse reactions to an investigational product(s); and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

 

Clinical Trial Regulations

 

Clinical trials regulated by BPOM consist of:

  1. Pre-Marketing Clinical Trials: conducted on investigational products that do not yet have a distribution permit in Indonesia or clinical trials with test products that already have a distribution permit with changes to the indications/efficacy claims, combinations, and/or posology
  2. Post-Marketing Clinical Trials: conducted on investigational products that have marketing authorization in Indonesia to obtain safety data and/or to confirm the approved efficacy

 

Pre-marketing and post-marketing clinical trials must obtain Clinical Trial Approval (CTA) from the BPOM. The implementation of clinical trials must adhere to the GCP guidelines as stated in:

BPOM Regulation No. 8 of 2024 on Procedures for Clinical Trial Approval 

CTA Submission

The CTA application is submitted by the Sponsor or Contract Research Organization (CRO) before the clinical trial is conducted. The CTA application is submitted through the SIAP-UK application at https://siap-uk.pom.go.id/ . If the SIAP-UK application encounters technical difficulties, the CTA application can be submitted via email to clinicaltrial@pom.go.id .

 

CTA Application Requirements 

CTA applications are submitted by attaching the following documents:

  1. Clinical Trial Documents
    • Clinical Trial Protocol
    • Informed Consent Form
    • Investigator's Brochure
    • Investigator's Statement
    • Sponsor's Statement
    • Investigator CV and GCP Certificate
    • Subject Insurance (if any)
    • Accreditation Certificate of the Designated Lab
    • Letter of Authorization (LoA) from Sponsor to CRO (if using CRO)
  2. Investigational Product Document
    • Certificate of Good Manufacturing Practices 
    • Summary Batch Protocol 3 consecutive batches (for biological products)
  3. Other Supporting Documents

 

CTA Application Flow

CTA is granted after obtaining approval from the Ethics Committee. Submission of CTA to BPOM can be done in parallel with the submission of Ethics Approval.

The following is the flow of CTA applications to BPOM:

 

 

CTA Application Fee

Sponsors or CROs make payments of 5 (five) million rupiah within a maximum of 10 (ten) calendar days from the date the Payment Order Letter (SPB) is issued.

 

CTA Submission Timeline

The results of the clinical trial evaluation must be submitted within a maximum period of 20 (twenty) working days from the date of payment using the time to respond mechanism.

The time to response mechanism in question is as follows:

  1. The calculation of the evaluation period is stopped if based on the evaluation results it requires improvements and/or additional data.
  2. The evaluation period calculation starts again from the beginning after the Sponsor or CRO submits corrections and/or additional data.  

 

The sponsor or CRO shall submit improvements based on BPOM's request no later than 100 (one hundred) working days from the date of issuance of the request.

 

In the event of a public health emergency determined by the government, the results of the evaluation of Clinical Trials for Drugs used in the context of dealing with the public health emergency condition shall be published within a maximum of 15 (fifteen) working days.

Clinical Trial Reporting

Serious Adverse Events (SAE)

A Serious Adverse Event (SAE) is Any unfavourable medical occurrence that is considered serious at any dose if it results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

SAE must be reported by the Principal Investigator to the Sponsor and Ethics Committee, and by the Sponsor to BPOM as follows:

Serious Adverse Drugs Reaction (SADR)

A Serious Adverse Drugs Reaction (SADR) is an unfavourable and unintended responses, such as a sign (e.g., laboratory results), symptom or disease related to any dose of a medicinal product where a causal relationship between a medicinal product and an adverse event is a reasonable possibility which result in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Sponsors are required to report serious adverse drugs reaction to BPOM as follows:

Sponsors must also report Suspected Unexpected Serious Adverse Reactions (SUSAR) of Investigational Product (not listed in the product information) from clinical trials in other countries involving clinical trial centers in Indonesia to BPOM.

SUSAR is an adverse reaction that meets three criteria: suspected, unexpected and serious.

Reporting of serious adverse drugs reactions is reported to BPOM using the following format: [Pdf] Serious Adverse Drugs Reactions Reporting Form. 

In addition to using the provided form format, Sponsors may use other reporting formats, provided they contain at least the minimum information required by that form.

 

Clinical Trial Report 

Sponsors are required to submit reports on the progress of Clinical Trials to BPOM with the following provisions:

  1. Every 6 (six) months: submitted using the following report format [Pdf] Clinical Trial Report Every 6 Months Format 
  2. At the end of the Clinical Trial: submitted no later than 30 working days from the end of the clinical trial using the following report format [Pdf] Clinical Trial Ending Report Format
  3. When the Clinical Trial is terminated prematurely: it must be submitted no later than 15 working days after the termination of the clinical trial, accompanied by the reasons for termination using the following report format [Pdf] Clinical Trial Termination Report Format


SAE, SADR, and Clinical Trial reports are submitted to BPOM via email clinicaltrial@pom.go.id .

GCP Inspection

GCP Inspection is an action taken by the regulator/BPOM to conduct an official review of documents, facilities, records and other sources deemed by the regulatory authority to be related to Clinical Trials (including bioequivalence testing), at the Clinical Trial Center, Sponsor's and/or CRO's fasilities, and/or at other locations related to the implementation of Clinical Trials. Inspections are carried out routinely or based on the existence of cases. Inspections can be carried out before/during/after the clinical trial is carried out.

 

The objectives of GCP inspections are to:

  • Assess compliance to the approved protocol, GCP standard, and applicable regulations.

  • ⁠Safeguard the rights, safety, and well-being of trial participants.

  • ⁠Verify the quality and integrity of clinical trial data.

  • ⁠Verify the controlled, maintained, and documented of investigational drugs.

 

GCP inspections are carried out by BPOM GCP inspectors as follows:

 

BPOM may appoint other personnel based on their competence and/or expertise to carry out GCP inspections.

 

 

Follow-up to GCP inspections can take the form of technical guidance and/or administrative sanctions.

Technical Guidance

Technical guidance is implemented if there are minor findings and/or fewer than 6 (six) major findings. Technical guidance is carried out by BPOM (Indonesian Food and Drug Authority) to provide guidance on corrective and preventive actions if, based on the monitoring results of Bioequivalence Study and/or Clinical Trial implementation, corrective actions are required.

Applicants, Bioequivalence Study Centers, Clinical Trial Centers, Principal Investigators, Sponsors, and/or CROs (Contract Research Organizations) are required to submit a Corrective Action Preventive Action (CAPA) report within a maximum deadline of 20 (twenty) working days starting from the date of the inspection results letter.

Remediation to the CAPA must be submitted within a maximum deadline of 20 (twenty) working days starting from the date of the request for remediation letter from BPOM. If the remediation cannot be submitted within the deadline, BPOM may impose follow-up actions in the form of administrative sanctions.

 

Administrative Sanctions

1. Warning, if:

  • there are 6 (six) or more major findings; and/or

  • there is no corrective action taken against the findings that formed the basis for the issuance of technical guidance in the previous monitoring results.

2. Stern Warning, if:

  • there is critical finding related to data integrity; and/or

  • there is no corrective action taken against the previous warning sanction.

3. Suspension of Clinical Trials for a maximum of 60 (sixty) days, if:

  • the violation has a serious impact on subject safety;

  • there is no corrective action taken against the severe warning sanction.

4. Termination of Clinical Trial implementation, if:

  • the violation has a serious impact on subject safety;

  • the violation has a serious impact on the reliability of Clinical Trial data;

  • there is no ethical approval from the Ethics Committee;

  • there is no corrective action taken against the clinical trial suspension sanction.

 

Information on the follow-up of GCP inspection results is detailed in: 

BPOM Regulation No. 9 of 2024 on Guidelines for Follow-up on Inspection Results of Drugs, Drug Ingredients, Narcotics, Psychotropics, Precursors, and Addictive Substances

 

CTA Submission Decision Data

Click on the selected Protocol Title to access the Evaluation Results Summary.

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No Protocol Title Phase Scope Sponsor CRO Clinical Trial Center Principal Investigator Investigational Product Type Investigational Product Name Submission Status Decision Date Implementation Status
1 A Phase I, Double-blinded, Randomized Controlled Study To Evaluate Safety And Immunogenicity Of Lipovaxin Tuberculosis Vaccine (bio Farma) In Healthy Populations Aged 18-40 Years In Indonesia I Local PT Bio Farma
Clinical Research Unit, Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta
Prof. Dr. dr. Sri Rezeki Hadinegoro, Sp.A(K)
 Vaccine Lipovaxin Approved 30-04-2026
2 Epidemiologi Dan Morbiditas Klinis Untuk Strongyloidiasis Beserta Pengobatannya Di Kabupaten Banjar, Provinsi Kalimantan Selatan: Uji Klinis Ivermectin III Local Fakultas Kedokteran, Kesehatan Masyarakat, dan Keperawatan, Universitas Gadjah Mada
 PT Hayya Life Science
Fakultas Kedokteran, Kesehatan Masyarakat, dan Keperawatan, Universitas Gadjah Mada
a. RSUD Ratu Zalecha, Banjar, Kalimantan Selatan
Prof. dr. E. Elsa Herdiana Murhandarwati, M.Kes., Ph.D
 Medicine Mectizan Approved 13-04-2026
3 Tenacity – A Phase Iii, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (probe) To Assess Efficacy And Safety Of I.v. Tenecteplase Vs Standard Of Care In Patients With Acute Ischemic Stroke (including Wake-up Stroke), Last Known Well >4.5 H With Imaging Evidence Of Salvageable Ischemic Tissue III Global Boehringer Ingelheim International GmbH
 PT IQVIA RDS Indonesia
1.RSUP Dr. Sardjito Yogyakarta
2.RS Bethesda Yogyakarta
3.RS Akademik Universitas Gadjah Mada
4.RS Universitas Airlangga
 Prof. Dr. dr. Ismail Setyopranoto, Sp.N., Subsp.NIOO(K)

1. Prof. Dr. dr. Ismail Setyopranoto, Sp.N., Subsp.NIOOK
2. Dr. dr. Rizaldy Taslim Pinzon, Sp.S, M.Kes
3. dr. Andre Stefanus Panggabean, Sp.N
4. dr. Yudhi Adrianto Sp.SK., FINR FINA
 Biological Product Metalyse (Tenecteplase) Approved 16-03-2026
4 Sstarlet: Shorter And Safer Treatment Regimens For Latent Tb II Global Research Institute of the McGill University Health Centre (RI-MUHC)
Research Center for Care and Control Infectious Disease, Universitas Padjadjaran
Prof. Rovina Ruslami, dr., Sp. PD, Ph. D
 Medicine Rifampicin Approved 16-03-2026
5 Phase I Randomized Double-blind Study On The Safety And Immunogenicity Of The Dtwp–hepatitis B–hib–sipv (bio Farma) Vaccine Administered After Birth-dose Priming With The Recombinant Hepatitis B (bio Farma) Vaccine In Indonesian Infants I Local PT Bio Farma
Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Padjadjaran, Bandung
Dr. Eddy Fadlyana, dr., Sp.A., Subsp.TKPSK., M.Kes.
 Vaccine Vaksin Hexavalent Approved 11-03-2026
6 Efficacy & Safety Of Piroxicam Plus Counterirritant Gel Compared With Others Topical Non-steroid Antiinflamation Drugs In Managing Musculoskeletal Pain : A Randomized Clinical Study IV Local PT. TAISHO PHARMACEUTICAL INDONESIA
Sports Medicine Clinic
a. Klinik Utama Eminence
b. St. Carolus Sports Clinic by Eminence
dr. Erica Kholinne, Sp.OT (K), Ph.D
 Medicine Counterpain PXM Canceled 18-02-2026
7 Uji Bioekivalensi Dengan Titik Akhir Klinis Brimonidine Tartrate 0,2% & Brinzolamide 1% Suspensi Tetes Mata Kombinasi Dosis Tetap Bebas Pengawet Dengan Produk Pembanding Untuk Menurunkan Tekanan Intraokular Yang Meningkat Pada Penderita Dewasa Dengan Glaukoma Atau Hipertensi Okular III Local PT Cendo Pharmaceutical Industries
Departemen Oftalmologi Fakultas Kedokteran Universitas Indonesia - Rumah Sakit Dr. Cipto Mangunkusumo
Dr. dr. Virna Dwi Oktariana, Sp.M(K)
 Medicine Suspensi tetes mata kombinasi Glopac B (Brimonidine tartrate 0,2% & Brinzolamide 1%) Approved 22-12-2025
8 A Revised Tafenoquine Dose To Improve Radical Cure For Vivax Malaria - Tafenoquine Dosing Revised (tadore) III Global Menzies School of Health Research
 PT Equilab International
Puskesmas Hanura, Lampung
 Associate Professor Kamala Thriemer

Prof. Dr. dr Erni Juwita Nelwan, PhD, SpPD-KPTI, FACP, FINASIM
 Medicine Tafenoquine (Kodatef) Approved 10-12-2025 Ongoing
9 Doxycycline Adjunctive Therapy To Reduce Excess Mortality And Complications From Central Nervous System Tuberculosis – Phase Ii Randomized Clinical Trial II Global National University Health System
CPL-USU General Hospital
a. Rumah Sakit Adam Malik
 Dr. Catherine Ong

dr. Inke Nadia Diniyanti Lubis, M. Ked (Ped), Sp. A, ph. D
 Medicine Doxycycline Approved 17-09-2025
10 A Phase 1/3, Open-label, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Immunogenicity Of Human Plasma-derived Factor Viii (skp-0141) For The Treatment And Prophylaxis In Male Patients With Severe Hemophilia A I/III Global SK Plasma Co., Ltd., Korea
 PT IQVIA RDS Indonesia
1.Siloam Hospitals Lippo Village, Tangerang
2.RSUP Dr. Hasan Sadikin, Bandung
3.Rumah Sakit Universitas Airlangga, Surabaya
4.RSUD Dr. Soetomo, Surabaya
5.RSUPN Dr. Cipto Mangunkusumo, Jakarta
6.RSUD Ulin, Banjarmasin
1. Dr. Dina Garniasih, Sp.A(K)
2. Dr. Amaylia Oehadian, Sp.PD-KHOM
3. Dr. Pradana Zaky Romadhon, Sp.PD, K-HOM
4. Prof. Dr. I Dewa Gede Ugrasena, dr. Sp.A(K)
5. Dr. dr. Novie Amelia Chozie, Sp.A(K)
6. dr. Wulandewi M, Sp.A, Subsp. H. Onk
 Biological Product Factor VIII, Human Plasma Derived Approved 02-09-2025 Not Started Yet
11 Randomized, Multicenter, Multinational, Double-blind Study To Compare The Pharmacokinetics, Efficacy, Safety And Immunogenicity Of Mb12 (proposed Pembrolizumab Biosimilar) Versus Keytruda® In Combination With Chemotherapy For The Treatment Of Patients With Advanced Stage Iv Non-squamous Non-small Cell Lung Cancer (nsclc) (benito Study) III Global mAbxience Research SLU
 PT Prodia Diacro Laboratories
1.MRCCC Siloam Hospital Semanggi
2.Siloam Hospital Lippo Village
3.Siloam Hospital Surabaya
4.Mayapada Hospital Kuningan
5.Mayapada Hospital Jakarta Selatan
6.Dharmais Cancer Hospital
1. dr. Sita Laksmi Andarini, PhD, SpP(K)
2. Prof. Dr. dr. Allen Widysanto, Sp.P, TTS, FAPSR
3. dr. Isnin Anang Marhana, Sp.P(K), FCCP, FISR, FAPSR
4. Prof. Dr. Dr. dr. Ikhwan Rinaldi, Sp.PD , Subsp. HOM, M.Epid, M.Pd.Ked, FINASIM, FACP, FISQua
5. DR. dr. Hilman Tadjoedin, Sp.PD-KHOM
6. Prof. Dr. dr. Noorwati Sutandyo, SpPD-KHOM
 Biological Product MB12 Canceled 21-08-2025 Not implemented
12 A Single-center, Randomized, Double-blind, Active- And Placebo-controlled, Phase 2, Therapeutic Exploratory Study To Evaluate The Safety And Efficacy Of The Dwp306001 In Patients With Overweight Or Obesity II Local Daewoong Pharmaceutical Co.,Ltd
 PT Equilab International
RS Dr. Cipto Mangunkusumo
dr. Dicky Levenus Tahapary, Sp.PD-KEMD, PhD, FINASIM
 Medicine Enavoglifozin/ Phentermine combination Canceled 18-08-2025 Not implemented
13 A Phase 3, Randomized, Double-blind, Placebo-controlled Study To Evaluate The Safety, Immunogenicity, And Efficacy Of V181 Dengue Vaccine In Healthy Participants 2 To 17 Years Of Age III Local PT. Merck Sharp and Dohme Indonesia
Departemen Ilmu Kesehatan Anak FK Universitas Indonesia-RSUPN Dr. Cipto Mangunkusumo
a. Puskesmas Kecamatan Kelapa Gading
b. Puskesmas Kecamatan Cipayung
c. Puskesmas Kecamatan Jatinegara
d. Puskesmas Kecamatan Pasar Minggu
dr. Mulya Rahma Karyanti, Sp.A(K),M.Sc
a. Dr. dr. Ari Prayitno, Sp. A(K)
b. Dr. dr. Bernie Endyarni Medise, Sp.A (K), MPH
c. dr. Nina Dwi Putri Sp.A(K), MSc(TropPaed)
d. dr. Pratama Wicaksana, Sp. A
 Vaccine V181 Dengue Vaccine Approved 14-08-2025 Ongoing
14 A Phase I Randomized, Double-blind, Placebo-controlled And Dose-escalation Study To Evaluate The Safety And Immunogenicity Of A Viral Vector-based Tuberculosis (tb) Vaccine Ad5-105k Against Tb Disease In Adults Aged 18 To 49 Years I Local PT. Etana Biotechnologies Indonesia
 PT. Increase Laboratorium Indonesia
Rumah Sakit Umum Pusat (RSUP) Persahabatan
a. Rumah Sakit Islam Jakarta (RSIJ) Cempaka Putih
Prof. Dr. dr. Erlina Burhan, MSc, SpP(K)
a. dr. Fanny Fachrucha, Sp.P(K)
 Vaccine Vaccine Ad5-105K Approved 14-05-2025 Ongoing
15 Methotrexate And Prednisolone Study In Erythema Nodosum Leprosum III Global London School of Hygiene & Tropical Medicine
RSUD Dr. Soetomo, Surabaya
Prof. Dr. M. Yulianto Listiawan, dr., Sp.DVE, Subsp. OBK, FINSDV, FAADV
 Medicine Methotrexate Approved 17-04-2025
16 A Phase 3, Randomized, Open Label Trial Comparing Efficacy And Safety Of Bgm0504 Versus Semaglutide Once Weekly As Add-on Therapy To Metformin In Patients With Type 2 Diabetes III Local BrightGene Bio-Medical Technology Co., Ltd
 PT. Tigermed Consulting Indonesia
1.RSUP Persahabatan
2.RSUPN Dr. Cipto Mangunkusumo
3.RS Universitas Indonesia
4.RS Fatmawati
 dr. Dicky Levenus Tahapary, Ph.D, Sp.PD-KEMD

1. dr. Adeputri Tanesha Idhayu, Sp.PD-KEMD
2. dr. Dicky Levenus Tahapary, Ph.D, Sp.PD-KEMD
3. Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD
4. dr. M. Ikhsan Mokoagow, MMedSci, Sp. P.D, Subsp. E.M.D. (K), FINASIM
 Medicine BGM0504 Approved 17-04-2025 Ongoing
17 Operational Research Of Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (c-tst) For Diagnosis Of Latent Mycobacterium Tuberculosis Infection In Populations Aged 18 Years To 65 Years Old In Indonesia IV Local PT Jakarta Biopharmaceutical Industry
Rumah Sakit Islam Jakarta
a. Puskesmas Cakung
b. Puskesmas Pulo Gadung
Prof. Dr. dr. Erlina Burhan, M.Sc, Sp.P(K)
a. Dr. dr. Fathiyah Isbaniah, Sp.P(K), M.Pd.Ked
b. dr Heidy Agustin, Sp.P(K)
 Biological Product RECOMBINANT MYCOBACTERIUM TUBERCULOSIS FUSION PROTEIN (EC) Approved 17-04-2025 Ongoing
18 Efektivitas Dan Keamanan Pemberian Terapi Tambahan Aquaresis Tolvaptan Pada Fase Awal Klinis Gagal Jantung Akut Pada Pasien Gagal Jantung Dengan Penurunan Fungsi Ventrikel Kiri IV Local dr Vireza Pratama Sp.JP(K) FIHA, FAsCC, FSCAI
RSUP Dr Sardjito
dr Vireza Pratama Sp.JP(K) FIHA, FAsCC, FSCAI
 Medicine Tolvaptan Canceled 15-04-2025 Not implemented
19 Shortened Regimen For Drug-susceptible Tuberculosis In Children (smile-tb) III Local Johns Hopkins Children’s Center Pediatric Infectious Diseases
Research Center for Care and Control Infectious Disease Universitas Padjadjaran
Prof. Rovina Ruslami, dr., Sp. PD, Ph. D.
 Medicine Rifapentin, Moxifloxacin, INH, Pirazinamide Approved 21-03-2025 Ongoing
20 Therapeutic Efficacy Study (tes) For Three Antimalarial Drugs (dihydroartemisinin- Piperaquine/dha-ppq, Artesunate-pyronaridine/aspy, Artemether- Lumefantrine/al) In Keerom And Yapen Regencies, Papua, Indonesia III Local Kementerian Kesehatan RI
Fakultas Kedokteran Universitas Hasanuddin
Prof. dr. Syafruddin, Ph.D
 Medicine Dihydroartemisinin-Piperaquin, Artesunate-Pyronaridine, Artemether-Lumefantrine Approved 06-02-2025 Ongoing
21 Single-blinded Study To Compare The Pharmacokinetic, Pharmacodynamic, And Safety Of Goserelin Acetate Injection With Reference Drug Zoladex® Injection (manufactured By Astrazeneca Uk, Registered By Astrazeneca Republic Of Korea) In Male Patients With Prostate Cancer - Preliminary Study Protocol No. Cr.125/eql/2023, Ver 4.0 Dated 2024-11-19 I Local Dongkook Pharmaceutical
 PT Equilab International
RSUD Dr. Soetomo
Dr. dr. Wahjoe Djatisoesanto, Sp.U(K)
 Medicine Goserelin Acetate Approved 17-01-2025 Ongoing
22 A Randomized, Double-blinded, Controlled Clinical Study To Evaluate Efficacy And Safety Of Intravaginal Microgest Soft Capsule In The Prevention Of Preterm Birth Of High Risk For Preterm Delivery Women III Local PT Lapi Laboratories
 PT. Equilab International
1.RSUPN dr. Cipto Mangunkusumo
2.RSUD dr. Soetomo
3.RSUD dr. Moewardi
4.RSUP dr. Hasan Sadikin
1. dr. Mohammad Adya Firmansha Dilmy, Sp.OG
2. Dr. dr. Ernawati Darmawan, Sp.OG(K)
3. dr. M. Adrianes Bachnas, Sp.OG(K)
4. dr. M. Alamsyah, Sp. OG-KFM (KIC), M.Kes
 Medicine Microgest Canceled 14-01-2025 Not implemented
23 Efikasi Analgetik Preemptif Ketamin Terhadap Nyeri Pasca Operasi Di Rsup Dr. Sardjito III Local dr. David Ferdiansyah
RSUP Dr. Sardjito
dr. David Ferdiansyah
 Medicine Ketamine Hydrochloride Canceled 06-01-2025 Not implemented
24 Efek Pemberian Phenylephrine Bolus Dengan Dosis Berbeda Untuk Mencegah Hipotensi Akibat Anestesispinal Pada Seksio Sesarea Di Rsup Dr.sardjito III Local dr.Ratih Kumala Fajar Apsari . M,.Sc, Sp.An-TI, KAO
RSUP Dr.Sardjito
dr.Ratih Kumala Fajar Apsari . M,.Sc, Sp.An-TI, KAO
 Medicine Phenylephrine Canceled 31-12-2024 Not implemented
25 Phase 3, Double-blind, Placebo-controlled Study Of Recce®327 Topical Gel For The Treatment Of Diabetic Foot Ulcer Infections III Local Recce Pharmaceuticals Ltd.
 PT INCREASE LABORATORIUM INDONESIA
Siloam Hospitals Lippo Village (SHLV)
Prof. Dr. dr. Em Yunir, Sp.PD-KEMD
 Medicine RECCE®327 Topical Gel Approved 04-12-2024 Ongoing
26 Single-blinded Study To Compare The Safety, Pharmacodynamic, And Pharmacokinetic Of Goserelin Acetate Injection (dongkook Pharmaceutical, Republic Of Korea) With Reference Drug Zoladex® Injection (manufactured By Astrazeneca Uk, Registered By Astrazeneca Republic Of Korea) In Male Patients With Prostate Cancer III Local Dongkook Pharmaceutical
 Equilab International
RSUD Dr. Soetomo
Dr. dr. Wahjoe Djatisoesanto, Sp.U(K)
 Medicine Gosereline Acetate Canceled 19-11-2024 -
27 A Multi-center, Randomized, Blinded, Active-controlled, Phase 3 Clinical Study To Evaluate The Immunogenicity And Safety Of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered With Hexavalent Vaccine At 2, 4 And 12-15 Months Of Age To Health Infants In Indonesia III Global Minhai Biotechnology Co., Ltd
 PT Prodia Diacro Laboratories
1.Program Studi Magister Ilmu Kesehatan Masyarakat FK Universitas Udayana
2.Departemen Ilmu Kesehatan Anak FK Universitas Padjadjaran/ RSUP dr. Hasan Sadikin Bandung
1. Dr.dr. I Gusti Ayu Trisna Windiani, SpA(K)
2. Dr. dr. Eddy Fadlyana, Sp.A(K)., MKes.
 Vaccine PCV Approved 01-10-2024 Ongoing
28 A Phase I/ii Randomized, Double-blind, Positive-controlled Dose-exploration Study To Evaluate The Safety And Immunogenicity Of A Virus-like Particle (vlp) Based Vaccine Against Poliomyelitis (vlp-polio) In Infants From 6 Weeks Of Age And Toddlers 12-18 Months Of Age I Local PT Etana Biotechnologies Indonesia
 Tigermed Consulting, Co., Ltd. Indonesia
1.RSUPN Dr. Cipto Mangunkusumo
a. Puskesmas Pulogadung
b. Puskesmas Sawah Besar
c. Puskesmas Cilincing
d. Puskesmas Cengkareng
e. Puskesmas Mampang Prapatan
2.RS Universitas Airlangga
a. Puskesmas Tambelangan
b. Puskesmas Banjar
 dr. Nina Dwi Putri, SpA.SubsIPT(K), MSc

1. dr. Nina Dwi Putri, SpA.SubsIPT(K), MSc
2. Prof. Dr. Nasronudin dr., Sp.PD., KPTI.FINASIM
 Vaccine Vaksin VLP-Polio Approved 01-10-2024 Ongoing
29 A Multi-centre Randomised Controlled Non-inferiority Trial To Compare The Efficacy, Safety And Tolerability Of Triple Artemisinin-based Combination Therapies Versus First-line Acts + Placebo For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Asia III Global University of Oxford
 Oxford University Clinical Research Unit Indonesia
FK Universitas Indonesia
a. Puskesmas Koya Barat
b. RSUD Ramela Muara Tami
Dr.dr. Erni J. Nelwan, PhD, SpPD, KPTI, FACP, FINASIM
 Medicine Triple Artemisinin Canceled 29-08-2024 Not implemented
30 A Multi-center, Randomized, Open-label, Investigator-initiated Trial Study To Evaluate Symptom Relief And Safety After Using Fexuprazan 40 Mg Compared To Esomeprazole 40 Mg In Patients With Gastroesophageal Reflux Disease (gerd). III Local Prof. Dr. dr. Ari Fahrial Syam, SpPD, K-GEH, MMB, FACP, FACG, FINASIM
 PT Equilab International
1.RS Universitas Indonesia
2.RS Islam Cempaka Putih
3.RS Menteng Mitra Afia
 Prof. Dr. dr. Ari Fahrial Syam, SpPD, K-GEH, MMB, FACP, FACG, FINASIM

1. dr. Muhammad Firhat Idrus, SpPD, K-GEH
2. dr. Ihsanil Husna, SpPD, FINASIM
3. dr. Dirga Sakti Rambe, SpPD, MSc.
 Medicine Fexuprazan Approved 23-07-2024 Ongoing
31 A Randomized, Double-blind, Multicenter, Phase Ii/iii Clinical Study Of Serplulimab In Combination With Bevacizumab And Chemotherapy (xelox) Versus Placebo In Combination With Bevacizumab And Chemotherapy (xelox) In First-line Treatment Of Patients With Metastatic Colorectal Cancer (mcrc) II/III Global Shanghai Henlius Biotech, Inc.
 PT Pharma Metric Labs
1.RS MRCCC Siloam Semanggi
2.RS Kariadi
3.RS Kanker Dharmais
 Prof. Dr. dr. Aru Wisaksono Sudoyo, SpPD-KHOM, FACP

1. dr. Ralph Girson Gunarsa Sp.PD-KHOM
2. Dr. dr. Eko Adhi Pangarsa, Sp.PD-KHOM, FINASIM
3. dr. Eka Widya Khorinal SpPD-KHOM, MPH
 Biological Product Serplulimab Approved 14-07-2024 Ongoing
32 A Phase Iii, Randomized, Investigator-blinded, Activecontrolled Study Of Efficacy And Safety Of Efepoetin Alfa For Treatment Of Anemia In Patients With Chronic Kidney Disease On Dialysis III Global Genexine, Inc.
 PT.Pharma Metric Labs
1.RSUPN Dr. Cipto Mangungkusumo
2.RSPAD Gatot Soebroto
3.RS Islam Jakarta Cempaka Putih
4.RSUP Dr. Hasan Sadikin Bandung
1. dr. Pringgodigdo Nugroho, Sp.PD-KGH
2. dr. Jonny, Sp.PD, KGH, M.Kes, MM
3. dr. Kuspudji Dwitanto R, Sp.PD-KGH
4. dr. Afiatin, Sp.PD-KGH
 Biological Product Efesa (Efepoetin Alfa) Approved 24-05-2024 Ongoing
33 Safety And Immunogenicity Of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally And Intramuscularly Via Needle-free Injection System II Local PharmaJet
 PT Prodia Diacro Laboratories
Departemen Kesehatan Anak FK Universitas Padjadjaran
Prof. Cissy B Kartasasmita
 Vaccine Vaksin gardasil viaPHARMAJET Tropis and Stratis Needle Free Injection System Canceled 25-04-2024 Not implemented
34 A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial To Assess The Prophylactic Efficacy, Safety, And Immunogenicity Of The Investigational M72/as01e-4 Mycobacterium Tuberculosis (mtb) Vaccine When Administered Intramuscularly On A 0,1-month Schedule To Adolescents And Adults III Global Bill & Melinda Gates Medical Research Institute
 PT IQVIA RDS Indonesia
1.FK Universitas Indonesia
2.RC3ID Universitas Padjadjaran
3.RSUP Persahabatan
4.RS Universitas Indonesia
5.RS Islam Jakarta Cempaka Putih
 Dr. dr. Erlina Burhan, Sp.P(K), MSc

1. Prof. Dr. dr. Sri Rezeki Hadinegoro, Sp.A(K)
2. Prof. Rovina Ruslami, dr., Sp.PD, PhD
3. Dr. dr. Fathiyah Isbaniah, M.Pd.Ked., Sp.P(K)
4. dr. Rania Imaniar, Sp.P
5. dr. Cut Yulia, Sp.P
 Vaccine M72/AS01E-4 Approved 19-04-2024 Ongoing
35 Pengaruh Pemberian Melatonin 20 Mg Terhadap Perubahan Nilai Limfosit Absolut, Rasio Neutrofil-limfosit Dan Kadar Prokalsitonin Pada Pasien Sepsis Dan Syok Sepsis III Local dr Vick Elmore Simanjuntak Sp An
RSUP Fatmawati
dr Vick Elmore Simanjuntak Sp An
 Medicine Melatonin Approved 22-03-2024 Ongoing
36 A Phase 3 Randomized, Double-blind, Placebo-controlled Study To Evaluate The Efficacy And Safety Of Bemnifosbuvir In High-risk Outpatients With Covid-19 III Global Atea Pharmaceuticals, Inc.
 IQVIA RDS Indonesia
Siloam Hospital
Dr. dr. Deddy Nur Wachid Achadiono, M.Kes, Sp.PD,KR
 Medicine Bemnifosbuvir Canceled 21-03-2024 -
37 A Phase 2, Open-label Study To Assess The Safety And Efficacy Of Bemnivosbuvir (bem) And Ruzasvir (rzr) In Subjects With Chronic Hepatitis C Virus (hcv) Infection II Global Atea Pharmaceuticals, Inc.
 IQVIA RDS Indonesia
1.RSUP Dr. Kariadi
2.RSUP Dr. Sardjito
1. Dr. dr. Hery Djagat Purnomo, Sp.PD,KGEH
2. Dr. dr. Neneng Ratnasari, Sp. PD,KGEH
 Medicine Bemnifosbuvir dan Ruzasvir Approved 28-02-2024 Canceled
38 Immunobridging Study: Immunogenicity And Safety Of Inavac (vaksin Merah Putih-unair Sars-cov-2 (vero Cell Inactivated)) Vaccine As Homologue Booster In Adult Subjects In Indonesia III Local PT Biotis
RSUD Dr. Soetomo, Surabaya
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
 Vaccine Inavac Approved 20-11-2023 Completed
39 Immunogenicity Of 23-valent Pneumococcal Polysaccharide Vaccine In Older Adults IV Local MERCK SHARP & DOHME INDONESIA
 Prodia DiaCRO Laboratories
Rumah Sakit Cipto Mangunkusumo
DR.dr. Kuntjoro Harimurti, Sp.PD. K-Ger
 Vaccine Pneumovac-23 Canceled 03-11-2023
40 Efficacy & Safety Of Paracetamol Syrup Versus Ibuprofen Suspension In The Management Of Fever In Pediatric Population Aged 2-15 Years Of Age: A Randomized Open Label Clinical Trial. III Local PT. Taisho
 Prodia DiaCRO Laboratories
Siloam Hospital
Dr. Yogi Prawira, Sp.A (K)
 Medicine Tempra forte Rejected 26-10-2023 -
41 A Multicenter, Randomized, Double-blinded, Positive Controlled Phase Ⅲ Clinical Trial To Evaluate Lot-to-lot Consistency, Immunogenicity And Safety Of Group Acyw135 Meningococcal Conjugate Vaccine (crm197) In Adults Aged 18 To 55 Years III Global CanSino Biologics Inc
 PT Etana Biotechnologies Indonesia
1.RS Universitas Airlangga
2.RS Husada Utama
 Dr. dr. Erni Juwita Nelwan, Ph.D, Sp.PD,KPTI, FACP, FINASIM

1. Prof. Dr. dr. Nasronudin, Sp.PD,KPTI, FINASIM
2. dr. Isti Suharjanti, Sp.S(K)
 Vaccine Menhycia Approved 26-10-2023 Ongoing
42 A Randomized, Observer Blinded, Active Controlled Phase 3 Study To Evaluate The Immunogenicity And Safety Of Candidate Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (hpv) Vaccine (escherichia Coli) Administered Intramuscularly In Healthy Female Participants Aged 18 To 45 Years III Global Beijing Health Guard Biotechnology, Inc
 PT. Equilab International
1.RSUP Dr. M. Djamil, Padang
2.RSU Universitas Udayana, Denpasar
a. Puskesmas I Denpasar Selatan
3.RSU Universitas Muhammadiyah Malang
1. dr. Asrawati, M. Biomed, Sp.A(K)
2. Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)
3. Prof. Dr. dr. Djoni Djunaedi, Sp.PD, KPTI
 Vaccine HPV Approved 29-09-2023 Ongoing
43 Safety Profile Of Booster Indovac Covid-19 Vaccination In Healthy Populations Aged 18 Years And Above IV Local PT Bio Farma
Komite Nasional Pengkajian dan Pengendalian Kejadian Ikutan Pasca Imunisasi(KOMNAS PP-KIPI)
Prof. Dr. dr. Hindra Irawan Satari, SpA(K), M.Trop.Paed
 Vaccine Indovac Canceled 27-09-2023
44 Immunobridging Study: Immunogenicity And Safety Of Vaksin Merah Putih – Ua Sars-cov-2 (vero Cell Inactivated) Vaccine As Homologous Booster In Adult Subjects In Indonesia III Local 1.Kemenkes RI
2.Unair
3.PT Biotis
RSUD Dr. Soetomo, Surabaya
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
 Vaccine Vero Cell Inactivated Canceled 14-09-2023 -
45 A Phase 3, Randomized, Blinded, Active-controlled Study To Evaluate The Immunogenicity And Safety Of Walvaxs 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (pcv13-tt) As Compared To Pfizers 13-valent Pneumococcal Conjugate Vaccine (pcv13) Co-ad III Local Yuxi Walvax Biotechnologies
 PT. Etana Biotechnologies Indonesia
1.RSUPN Dr. Cipto Mangunkusumo, Jakarta
2.Fakultas Kedokteran Universitas Udayana, Denpasar, Bali
a. Puskesmas 1 Denpasar Selatan
b. Puskesmas 2 Denpasar Utara
c. Puskesmas 3 Denpasar Utara
1. Dr. dr. Nastiti Kaswandari. ApA(K)
2. Dr.dr. I Gusti Ayu Trisna Windiani, SpA(K)
 Vaccine PCV13-TT Approved 13-09-2023 Ongoing
46 A Randomized Trial Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1hp) To Weekly Rifapentine & Isoniazid For 3 Months (3hp) In Persons Living With Hiv And In Hiv Negative Household Contacts Of Recently Diagnosed Tuberculosis Patients, The -one To Three- Trial IV Global 1.Yayasan KNCV Indonesia
2.The Aurum Institute
RSUP. Persahabatan
Prof. Dr. dr. Erlina Burhan M.Sc.,Sp.P(K)
 Medicine Kombinasi Rifapentine dan Isoniazid Approved 13-09-2023 Ongoing
47 Immunobridging Study: Immunogenicity And Safety Of Vaksin Merah Putih - Ua Sars-cov-2 (vero Cell Inactivated) Vaccine As Heterologue Booster In Adolescent Subjects In Indonesia III Local 1.Badan Kebijakan Pembangunan Kesehatan
2.Universitas Airlangga
3.PT Biotis
RSUD. Dr. Soetomo, Surabya
Dr. Dominicus Husada, dr., SpA(K)
 Vaccine Inavac Approved 13-09-2023 Ongoing
48 A Prospective, Multicenter, Single-arm Clinical Study Evaluating The Use Of Ucmsc Secretome For Dermal Resurfacing III Local PT Bifarma Adiluhung
RSUPN Dr. Cipto Mangunkusumo
dr. Sondang MHA Pandjaitan Sirait, SpKK(K), MPd.Ked, FINSDV, FAADV
 Biological Product Secretom dermal Canceled 24-07-2023 -
49 Immunogenicity & Safety Of Indovac As A Homologous Booster Dose Against Covid-19 In Adults Aged 18 Years And Above In Indonesia III Local PT Bio Farma
 PT Equilab International
Fakultas Kedokteran Universitas Diponegoro
dr. Yetty Movieta Nency, Sp.A.(K)
 Vaccine IndoVac Approved 18-07-2023 Completed
50 Effectivenesss & Safety Of Ovine Enoxaparin Sodium To Originator Enoxaparin In Non-st-segment Elevation Acute Coronary Syndrome (nsteacs) Patients: A Multicenter, Non-randomized, Open-label, Non-inferiority Trial IV Local PT Bio Farma
 Clinical Epidemiology and Biostatistics Unit (CEBU) FKKMK Universitas Gadjah Mada
1.RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta
2.RSUP Dr. Sardjito, Yogyakarta
3.RSUP Prof. Dr. I.G.N.G Ngoerah, Denpasar
dr. Bambang Widyantoro, Sp.JP(K), Ph.D

1. Dr. dr. Dafsah Arifa Juzar, Sp.JP(K)
2. dr. Hendry Purnasidha Bagaswoto, Sp.JP(K)
3. Dr. dr. I Made Junior Rina Artha, Sp.JP(K)
Medicine Ovine Enoxaparin Approved 27-06-2023 Completed
51 Safety And Immunogenicity Of Indovac® In Healthy Children Aged 6-11 Years In Indonesia II Local PT Bio Farma
 PT Equilab International
Fakultas Kedokteran Universitas Diponegoro, Semarang
dr. Yetty Movieta Nency, Sp.A (K)
 Vaccine IndoVac Canceled 19-05-2023 -
52 A Randomized, Observer Blinded, Active Controlled Phase 3 Study To Evaluate The Immunogenicity And Safety Of Candidate Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (hpv) Vaccine (escherichia Coli) Administered Intramuscula III Global 1.PT Etana Biotechnologies Indonesia
2.Beijing Health Guard Biotechnology Inc
 PT. Equilab International
1.RSUP M. Djamil Padang
2.RSU Universitas Udayana
3.RSU Universitas Muhammadiyah Malang
1. dr. Asrawati, M.Biomed, Sp. A(K).
2. Dr. dr. I Gusti Ayu Trisna Windiani, SpA (K)
3. Prof. DR.dr. Djoni Djunaedi, Sp.PD,KPTI, FINASIM
 Vaccine HPV Rejected 03-05-2023 -
53 An Open Label, Phase Iii Clinical Trial (immunobridging Study) Of Inavac (vaksin Merah Putih - Ua-sars Cov-2 (vero Cell Inactivated)) In Healthy Population Aged 12 To 17 Years Old III Local 1.Badan Kebijakan Pembangunan Kesehatan
2.Universitas Airlangga
3.PT Biotis
RSUD. Dr. Soetomo, Surabya
Dr. Dominicus Husada, dr., SpA(K)
 Vaccine Inavac Approved 26-04-2023 Completed
54 Vaksinasi/vaksinasi Ulang Bcg Sebagai Pencegahan Infeksi Mycobacterium Tuberculosis Pada Mahasiswa Kedokteran Dan Keperawatan Yang Akan Memulai Pendidikan Profesi: A Randomised Placebo-controlled Proof Of Principle Trial (pop Bcg Trial). - Local University of Otago
Research Center for Care and Control Infectious Disease Universitas Padjadjaran
dr. Lika Apriani, MSc, Ph.D
 Vaccine Vaksin BCG Kering Approved 21-03-2023 Completed
55 Immunogenicity And Safety Of Indovac® As A Heterologous Booster Dose Against Covid-19 In Children 12-17 Years Of Age II Local PT Bio Farma
 PT Equilab International
Departemen Ilmu Kesehatan Anak FK Unpad, Rumah Sakit Hasan Sadikin, Bandung
Dr. Eddy Fadlyana, dr.,SpA(K), M Kes
 Vaccine IndoVac Approved 13-02-2023 Completed
56 Safety And Immunogenicity Of Vaksin Merah Putih Ua-sars-cov-2 (vero Cell Inactivated) Vaccine In Healthy Population Aged 6 To 11 Years Old (phase Ii/iii) II/III Local 1.Badan Kebijakan Pembangunan Kesehatan
2.Universitas Airlangga
3.PT Biotis
RSUD Dr. Soetomo, Surabaya
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
 Vaccine Vaksin Merah Putih (Vero Cell Inactivated) Canceled 06-02-2023 -
57 A Randomized, Double Blind, Controlled, Phase Iii Clinical Trial (immunobridging Study) Of Vaksin Merah Putih Ua Sars-cov-2 (vero Cell Inactivated) In Healthy Population Aged 12 To 17 Years Old. III Local 1.Badan Kebijakan Pembangunan Kesehatan
2.Universitas Airlangga
3.PT Biotis
RSUD Dr. Soetomo, Surabaya
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
 Vaccine Vaksin Merah Putih (Vero Cell Inactivated) Canceled 06-02-2023 -
58 Profil Keamanan Diphtheria Antitoxin (dat) Di Indonesia IV Local PT Bio Farma
RSUD Dr. Soetomo, Surabaya
Dr. Dominicus Husada, dr., SpA(K)
 Medicine Diphtheria Antitoxin B.P Approved 25-01-2023 Completed
59 A Randomized, Double-blind, Placebo-controlled Clinical Study To Evaluate The Efficacy, Safety, And Immunogenicity Of Sars-cov-2 Variant (ba.4/5) Mrna Vaccine (abo1020) In Healthy Subjects Aged 18 Years And Older Who Have Completed The Full Vaccination II/III Global 1.PT Etana Biotechnologies Indonesia
2.Suzhou Abogen Biosciences Co., Ltd. China
 PT. Tigermed Consulting Indonesia
1. RSUP Persahabatan Jakarta
2. RSUPN dr. Cipto Mangunkusumo
3. RSUD Tarakan Jakarta/
4. Rumah Sakit Universitas Indonesia Depok
5. Rumah Sakit Islam Jakarta Cempaka Putih
6. Rumah Sakit YARSI
1. dr. Raden Rara Diah Handayani, Sp.P(K)
2. dr. Ceva Wicaksono Pitoyo, SpPD, KP, KIC, FINASIM
3. dr. Indawati, Sp.P
4. dr. Rania Imaniar, Sp.P
5. dr. Cut Yulia Indah Sari, Sp.P
6. dr. Efriadi Ismail, Sp.P
 Vaccine mRNA SARS-COV-2 Omicron BA 4/5 Approved 18-01-2023 Ongoing
60 Immunogenicity And Safety Following In-house Recombinant Hepatitis B (bio Farma Vaccine Compared To Hepatitis B (bio Farma) Vaccine In Indonesian Population III Local PT. Bio Farma
RSUP Prof. I.G.N.G Ngoerah
Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)
 Vaccine Hepatitis B Approved 15-11-2022 Not Started Yet
61 A Phase Iii, Observer-blind, Randomized, Controlled Study Of The Safety And Immunogenicity Of Sars-cov-2 Protein Subunit Recombinant Vaccine In Healthy Children Aged 12-17 Years In Indonesia III Local PT. Bio Farma
 PT Equilab International
1.CCH PRO UGM
2.FK Universitas Andalas
1. dr. Cahya Dewi Satria, M.Kes., Sp.A(K)
2. dr. Asrawati, M.Biomed., Sp.A(K)
 Vaccine Indovac Approved 30-09-2022 Completed
62 A Randomized, Double-blind, Placebo-controlled, Phase Iii Study To Evaluate The Efficacy And Safety Of Proxalutamide (gt0918) In Hospitalized Covid-19 Subjects” III Global PT. Kintor
 Tigermed
1.Rumah Sakit Universitas Airlangga
2.Rumah Sakit Sentra Medika
1. Prof. Dr. Nasronudin, dr., Sp.PD., KPTI., FINASIM.
2. dr. Lusi Nursilawati Syamsi, Sp.P,FCCP, FAPSR, M.Farm.
 Medicine Proxalutamide Approved 12-09-2022 Prematurely Terminated
63 Observer-blind, Randomized, Controlled Study Of Immunogenicity And Safety Of Sars-cov-2 Protein Subunit Recombinant Vaccine (bio Farma) As A Booster Dose Against Covid-19 In Adults 18 Years Of Age And Older III Local PT. Bio Farma
 PT Equilab International
1.Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Padjadjaran
2.Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Udayana
1. Prof. Dr. Kusnandi Rusmil, dr., SpA(K), MM
2. Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)
 Vaccine Vaksin SARS-CoV-2 -PT. Bio Farma ajuvan alum CPG Approved 30-08-2022 Completed
64 Immunobridging Study: Immunogenicity And Safety Of Vaksin Merah Putih Ua Sars-cov-2 (vero Cell Inactivated) Vaccine As Heterologus Booster In Adult Subjects In Indonesia III Local 1.Kemenkes RI
2.PT. Biotis
3.Universitas Airlangga
RSUD Dr. Soetomo, Surabaya
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
 Vaccine Vaksin Merah Putih (Vero Cell Inactivated) Approved 26-08-2022 Completed
65 A Parallel Group Treatment, Phase 2/3, Double-blind,randomized, Placebo-controlled, 2-arm Study To Evaluate The Safety, Tolerability, And Efficacy Of Ad17002 (lth[αk]) Intranasal Spray In Male And Female Participants Aged 18 To 65 Years With Mild To Moderate Covid-19 II/III Local Departemen Farmakologi UGM
 PT Equilab International
Departemen Farmakologi UGM
dr. Dwi Aris Agung Nugrahaningsih, M.Sc., Ph.D.
 Medicine AD17002 / Heat Labile E Coli Approved 18-07-2022 Ongoing
66 A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Intravenous Administration Of Hzvsf-v13 As Add-on To Standard Of Care Compared To Placebo Plus Standard Of Care In Subjects With Severe Coronavirus Disease 2019 III Global ImmuneMed Inc
 PT Prodia DiaCRO Laboratories
RSUP Persahabatan
 dr. Prasenohadi, Sp.PKIC, Ph.D

dr. Erlina Burhan M.Sc., Ph.D
 Medicine hzVSF-v13 Approved 27-06-2022 Completed
67 A Multicenter, Randomized, Double Blind, Controlled, Phase Iii Clinical Trial (immunobridging Study) Of Vaksin Merah Putih Ua Sars-cov-2 (vero Cell Inactivated) In Healthy Population Aged 18 Years And Above III Local Kemenkes RI
RSUD Dr. Soetomo, Surabaya
a. RS Universitas Airlangga, Surabaya
b. RSUD. Dr. Saiful Anwar, Malang
c. RS Paru, Jember
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
a. Prof. Dr. Nasronudin, dr., Sp.PD., KPTI. FINASIM
b. Dr. Dr. Caesarius Singgih Wahono, Sp.PD, KR
c. dr. Sigit Kusuma Jati, MM
 Vaccine Vaksin Merah Putih (Vero Cell Inactivated) Approved 24-06-2022 Completed
68 Immunogenicity & Safety Of Sars-cov-2 Protein Subunit Recombinant Vaccine (bio Farma) Adjuvanted With Alum+cpg 1018 Compared To Registered Covid-19 Vaccine (covovax – Protein Subunit Vaccine) In Healthy Populations Aged 18 Years And Above In Indonesia (phase Iii) III Local PT. Bio Farma
1.Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Indonesia
2.Fakultas Kedokteran Universitas Diponegoro, Semarang
3.Fakultas Kedokteran Universitas Andalas
4.Fakultas Kedokteran Universitas Hasanuddin
 Prof. Dr. dr. Soedjatmiko, SpA(K), M.Si

1. Prof. Dr. dr. Rini Sekartini, SpA (K)
2. dr. Yetty Movieta Nency, Sp.A.(K)
3. dr. Asrawati, M.Biomed, SpA(K)
4. Dr. dr. Martira Maddeppungeng, Sp.A(K)
 Vaccine Vaksin SARS-CoV-2 -PT. Bio Farma Approved 06-06-2022 Completed
69 A Randomized, Double-blind, And Placebocontrolled Phase 1 Clinical Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Sars-cov-2 Variant Mrna Vaccines (abo1009-dp And Abocov.61-2) In Indonesian Subjects Aged 18 Years And Older Who Have Not Received Sars-cov-2 Vaccines I Global 1.Suzhou Abogen Biosciences Co., Ltd
2.PT Etana Biotechnologies Indonesia
 PT. Tigermed Consulting Indonesia
1.RSUP Persahabatan
2.RSUPN Dr. Cipto Mangunkusumo
1. Dr. dr. Fathiyah Isbaniah, Sp. P(K), MPd, Ked
2. dr. Sukamto Koesnoe, Sp.PD,KAI
 Vaccine Vaksin SARS CoV-2 mRNA Variant Omicron dan Delta Approved 02-06-2022 Completed
70 An International Multicenter, Randomized, Double-blind, Placebo-controlled Trial Of The Safety And Efficacy Of Anti-coronavirus Hyperimmune Intravenous Immunoglobulin For The Treatment Of Adult Outpatients In Early Stages Of Covid-19 Protocol No: Insight 012 III Global Badan Litbangkes Kementrian Kesehatan RI
1.RSUP Sanglah, Denpasar
2.RSUP Wahidin Sudirohusodo, Makassar
3.RSUP Hasan Sadikin, Bandung
1. Dr. dr. I Ketut Agus Somia, Sp.PD-KPTI, FINASIM
2. dr. Nurjannah Lihawa, SpP
3. dr. Rudi Wisaksana, SpPD-KPTI, PhD
 Biological Product Anti-coronavirus Hyperimmune Intravenous lmmunoglobulin Approved 02-06-2022 Prematurely Terminated
71 Efficacy And Tolerability Of Adjunct Metformin In Combination With Multidrug Treatment For Multibacillary Leprosy: A Randomized Double-blind, Controlled Proof Of-conce-pt Phase 2 Trial In Indonesia (metlep) II Local University of Oxford
 Eijkman Oxford Clinical Research Unit (EOCRU)
Departemen Dermatologi dan Venerologi UGM Yogyakarta
a. Puskesmas Hamadi, Papua
b. Puskesmas Abe Pantai, Papua
c. Puskesmas Jayapura Utara, Papua
Prof. Dr. dr. Hardyanto Soebono Sp.KK(K)
 Medicine Metformin XR Approved 28-04-2022 Ongoing
72 A Randomized, Double-blinded, Positive Controlled Phase Iib Clinical Trial To Evaluate The Immunogenicity And Safety Of Covid-19 Vaccine (vero Cell), Inactivated Booster Dose In Adults Who Have Completed Two Doses Of Coronavac Or Vaxzevria In Indonesia II Global Sinovac Life Sciences Co., Ltd.
RS Universitas Indonesia
dr. Robert Sinto, SpPD, KPTI
 Vaccine Inactivated Booster Canceled 27-04-2022 -
73 A Phase 2/3, Double-blind, Randomized, Placebo-controlled Study Of The Efficacy, Safety And Immunogenicity Of Sars-cov-2 Protein Subunit Recombinant Vaccine (bio Farma) Adjuvanted With Alum+cpg 1018 In Healthy Populations Aged 18 Years And Above In Indonesia II/III Local PT. Bio Farma
 PT Equilab International
1.Fakultas Kedokteran Universitas Diponegoro, Semarang
2.Fakultas Kedokteran Universitas Andalas
3.Fakultas Kedokteran Universitas Hasanuddin
 Prof. Dr. dr. Soedjatmiko, SpA(K). M.Si

1. dr. Yetty Movieta Nency, Sp.A.(K)
2. dr. Asrawati, M.Biomed, SpA(K)
3. Dr. dr. Martira Maddeppungeng, Sp.A(K)
 Vaccine Vaksin SARS-CoV-2 -PT. Bio Farma ajuvan alum CPG Approved 11-04-2022 Completed
74 A Global, Multi-center, Randomized, Double-blind, Placebo-controlled Phase Iii Clinical Trial To Evaluate The Protective Efficacy And Safety Of Influenza Virus Vector Covid-19 Vaccine For Intranasal Spray (delns1-2019-ncov-rbd-o-pt1) In Adults Aged 18 Years And Older III Global Beijing Wantai Biological Pharmacy
 PT. Tigermed Consulting Indonesia
1.RSGM Universitas Jember
2.RS Universitas Sebelas Maret
3.RS Husada Utama
4.RS Universitas Kristen Krida Wacana
5.RS Sri Pamela
1. dr. Ulfa Elfiah, M.Kes,Sp.BPRE(K)
2. Prof. Dr. Hartono, dr, M.Si
3. dr. Didi D. Dewanto, Sp.OG
4. dr. Wiliam., Sp.FK
5. Dr. Hj. Sake Juli Martina, Sp.FK
 Vaccine Vaksin COVID-19 Intranasal (Viral Vector) Rejected 22-02-2022 -
75 Stop Transmisi Kusta Pep++ III Global NLR Indonesia
RSUD Dr. Soetomo, Surabaya
Prof. Dr. dr. Cita Rosita Sigit Prakoeswa
 Medicine Rifampicin, Klaritromicin Approved 22-02-2022 Canceled
76 A Phase I, Observer-blind, Randomized, Controlled Study Of The Safety And Immunogenicity Of Sars-cov-2 Protein Subunit Recombinant Vaccine (adjuvanted With Alum+cpg 1018) In Healthy Populations Aged 18 Years And Above In Indonesia I Local PT. Bio Farma
1.Departemen Ilmu Kesehatan Anak, FK Universitas Indonesia
a. Puskesmas Tapos
b. Puskesmas Cilangkap
c. Puskesmas Jati Jajar
2.FK Universitas Diponegoro, Semarang
a. Puskesmas Pecangaan
1. Prof. Dr.dr. Rini Sekartini, SpA (K)
2. dr. Yetty Movieta Nency, Sp.A.(K)
 Vaccine Vaksin SARS-CoV-2 -PT. Bio Farma ajuvan alum CPG Approved 14-02-2022 Completed
77 Safety And Immunogenicity Of Unair Inactivated Covid-19 Vaccine In Healthy Population Aged 18 Years And Above (phase I/ii) I/II Local 1.Kemenkes RI
2.PT. Biotis
3.UNAIR
RSUD Dr. Soetomo, Surabaya
Dr. Dominicus Husada, dr., Sp.A(K)
 Vaccine UNAIR Inactivated Covid-19 Vaccine Approved 05-02-2022 Completed
78 Immunogenicity And Safety Study Of Half Dose Of Moderna Covid-19 Vaccine Booster Heterologous In Adult Subjects In Indonesia III Local Badan Litbangkes, Kementerian Kesehatan RI
FK Universitas Indonesia
a. Puskesmas Cempaka Putih
dr. Nina Dwi Putri, Sp.A(K).
 Vaccine Vaksin Booster Moderna Approved 02-02-2022 Completed
79 A Clinical Trial To Evaluate The Immunogenicity And Safety Of Heterologous Prime Boost Vaccination Of Recombinant Novel Coronavirus Vaccine (cho Cell) After Two Doses Of Inactivated Covid-19 Vaccine Or Two Doses Non-replicating Viral Vector Covid-19 Vaccine Of In Healthy Subjects Aged 18 Years Old And Over III Global Anhui Zhifei Longcom Biopharmaceutical Co., Ltd
 PT Equilab International
Dept. Ilmu Kesehatan Anak FK-UNPAD
Dr. Rodman Tarigan, Sp.A (K), M.Kes
 Vaccine Recombinant Novel Coronavirus Vaccine Canceled 31-01-2022
80 A Phase Ii/iii, Double-blind, Randomized, Placebo-controlled Clinical Trial To Evaluate The Efficacy Of Ruti To Reduce The Severity Of Sars-cov-2 Infection II/III Global PT Innovative Pharma Solutions
 PT. Biometrik Riset Indonesia
1.RSUP Persahabatan
a. Puskesmas Pademangan
b. Puskesmas Tanjung Priok
c. Puskesmas Cilincing
2.RSDC Wisma Atlet Kemayoran
1. Dr. dr. Fathiyah Isbaniah, Sp. P(K), M.Pd. Ked.
2. Dr. Efriadi Ismail, Sp.P
 Medicine RUTI Approved 27-01-2022 Canceled
81 Bevacizumab Compared To Avastin In Combination With Capecitabine Plus Oxaliplatin (capeox) As First Line Therapy In Metastatic Colorectal Cancer: A Preliminary Open-label Study III Local PT Etana Biotechnologies Indonesia
 CRSU FKUI
Rumah Sakit Kanker Dharmais
dr. Ronald Alexander Hukom, Sp.PD, KHOM, MHSC, FINASIM
 Medicine Bevacizumab Approved 21-01-2022 Prematurely Terminated
82 A Phase 2, Double Blind, Randomized, Placebo Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Dwrx2003 In Combination With Remdesivir Following Intramuscular Administration In Moderate-severe Covid-19 Patients II Global 1.Litbangkes, Kemenkes RI
2.Daewoong Pharmaceutical
 INA RESPOND
1.RSUP Dr. Hasan Sadikin, Bandung
2.RSUPN Dr. Cipto Mangunkusumo, Jakarta
3.RSPAL Dr. Ramelan, Surabaya
 Dr. Muhammad Karyana, M.Kes

1. dr. Bachti Alisjahbana, Sp.PD KPTI, PhD
2. dr. Mira Yulianti, Sp.PD, KP
3. Dr. Gunady Wibowo R. Sp.PD,KGEH
 Medicine Niclosamide Approved 05-01-2022 Prematurely Terminated
83 A Phase Ii Non-randomized Open Labelled Clinical Trial To Evaluate The Safety & Immunogenicity Of Sarscov-2 Vaccine (vero Cell) Inactivated As A Booster Dose II Local PT Kimia Farma
1.Rumah Sakit JIH, Yogyakarta
2.Rumah Sakit Bali Mandara, Bali
3.Rumah Sakit Universitas Udayana, Bali
4.RSUD dr. Saiful Anwar, Jawa Timur
5.RSUD Ulin Banjarmasin, Kalimantan Selatan
6.Lab Klinik Kimia Farma Radio Dalam, Jakarta
7.Lab Klinik Kimia Farma Adisucipto, Yogyakarta
8.Lab Klinik Kimia Farma Sutomo Semarang
9.Lab Klinik Kimia Farma Diponegoro, Bandung
 dr. Prenali Dwisthi Sattwika, SpPD

1. dr. Deshinta Putri Mulya, Sp.PD-KAI
2. dr. I Ketut Agus Somia, Sp.PD
3. dr. Cokorda Wahyu Purnamasidhi, M.Biomed., Sp.PD
4. dr. Muhammad Anshory, Sp.PD
5. dr. Nanang Miftah Fajari, Sp.PD-KEMD
6. dr. Andi Wiradharma, Sp.PK
7. dr. Nuur Naafi Ulloh, M.Sc, Sp.PK
8. Dr.dr.I. Edward KSL, MM, MHKES, SpPK(K), M.Si.Med
9. dr. Dewi Rinakanti, Sp.PK
 Vaccine SARS-COV-2 Vaccine (Vero Cell) Inactivated Approved 28-12-2021 Completed
84 A Global, Multi-center, Randomized, Double-blind, Placebo-controlled, Phase Iii Clinical Study To Evaluate The Efficacy, Safety, And Immunogenicity Of Sequential Immunization Of Recombinant Sars-cov-2 Fusion Protein Vaccine (v-01) Against Covid-19 In Healthy Adults Aged 18 Years And Older After The Vaccination Of 2 Doses Of Inactivated Vaccines III Global Livzon Mabpharm Inc. / Jiaming Yang
1.Fakultas Kedokteran Universitas Islam Negeri Syarif Hidayatullah
2.RSUP Sanglah
dr. Hari Hendarto, PhD, SpPD-KEMD, FINASIM
 Vaccine SARS-CoV-2 Fusion Protein Vaccine (V-01) Rejected 28-12-2021
85 A Phase I, Observer-blind, Randomized, Controlled Study Of The Safety And Immunogenicity Of Sars-cov-2 Protein Subunit Recombinant Vaccine In Healthy Populations Aged 18 Years And Above In Indonesia I Local 1.PT Bio Farma
2.Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan RI
Departemen Ilmu Kesehatan Anak FK Universitas Indonesia
a. Puskesmas Pancoran Mas, Depok
Prof. Dr. Rini Sekartini, Sp.A(K)
 Vaccine SARS-CoV-2 Protein Subunit Recombinant Vaccine Approved 06-12-2021 Completed
86 Uji Klinik Fase Iii, Acak, Terbuka Pemberian Terapi Tambahan Bamlanivimab-etesevimab Pada Pasien Covid-19 Derajat Ringan Sedang III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
1.RSPI Prof Sulianti Saroso
2.RSUP Dr. Wahidin Sudirohusodo
3.RSJ Soerodjo, Magelang
4.RSUP Sardjito, Yogyakarta
5.RSUP Hasan Sadikin, Bandung
6.RSUP Surakarta
7.RS Universitas Sebelas Maret
8.RSUPN Dr. Cipto Mangunkusumo, Jakarta
9.RS Universitas Airlangga
10.RS Universitas Sumatera Utara
 Dr. dr. Armedy R. Hasugian, M. Biomed

1. Dr. Herlina, SpPD
2. dr. Irawati Djaharuddin, SpP(K)
3. Dr. Harly SpPD, KEMD
4. dr. Bambang Sigit Riyanto, SpPD KP, FINASIM
5. Dr. Laniyati Hamijoyo, dr., SpPD KR., M.Kes.
6. dr. Makiyatul M, SpPD
7. dr. Tonang Dwi Ardyanto, Sp.PK, PhD, FISQua
8. Dr. Nina Dwi Putri, SpA(K), M.Sc (TropPaed)
9. dr. Wiwin Is Effendi, SpP(K), PhD
10. Dr Inke Lubis SpA, PhD
 Medicine Bamlanivimab -Etesevimab Approved 06-12-2021 Completed
87 Safety And Tuberculin Conversion Following Bcg Vaccine Vial (bio Farma) Compared To Registered Bcg Vaccine (bio Farma) In Indonesian Infants” II Local PT Bio Farma
Departemen Ilmu Kesehatan Anak RSUD Dr. Soetomo Surabaya
Dr. Dominicus Husada, dr., Sp.A(K)
 Vaccine Vaksin BCG Approved 22-11-2021 Completed
88 Studi Klinis Fase Iii, Acak, Tersamar Ganda, Terkontrol Plasebo Untuk Mengevaluasi Efikasi Dan Keamanan Proxalutamide (gt0918) Pada Pasien Rawat Inap Covid-19 III Local PT Etana Biotechnologies Indonesia
 CRSU FKUI
1.RSUP Persahabatan
2.RSUPN Dr. Cipto Mangunkusumo
3.RS Pelni
4.RS Pertamina Pusat
5.RSUD Pasar Minggu
6.RSUD Cengkareng
 dr. Triya Damayanti, SpP(K), PhD

1. Dr. dr. Erlina Burhan, MSc, SpP(K)
2. Dr. dr. Andhika Rachman, SpPD KHOM
3. dr. Prasenohadi, PhD, SpP(K), KIC
4. dr. Wahyuningsih Suharno, SpP
5. dr. Sri Dhuny Atas Asri, Sp.P.FISR
6. dr. Puji Astuti, Sp.P
 Medicine Proxalutamide Approved 19-11-2021 Prematurely Terminated
89 Immunogenicity And Safety Study Of Half And Full Doses Of Heterologous And Homologous Covid19 Vaccine Booster In Adult Subjects In Indonesia. II Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
1.FK Universitas Padjadjaran
2.FK Universitas Indonesia
 Dr. Eddy Fadlyana, dr., Sp.A(K)., Mkes

1. Dr. Djatnika Setiabudi, dr., SpA(K)
2. dr. Nina Dwi Putri, Sp.A(K)
 Vaccine Sinovac, AstraZeneca, Pfizer Approved 17-11-2021 Completed
90 A Global, Multi-center, Randomized, Double-blind, Placebocontrolled, Phase Iii Clinical Study To Evaluate The Efficacy, Safety, And Immunogenicity Of Recombinant Sars-cov-2 Fusion Protein Vaccine (v-01) In Adults Aged 18 Years And Older (nomor Protokol : Tg2101v01, Version 2.0 June 14, 2021) III Global Livzon Mabpharm Inc.
 PT Equilab International
1.Pusat Riset Pengelolaan dan Pengendalian Penyakit Infeksi Direktorat Riset dan Pengabdian Masyarakat, Universitas Padjadjaran
2.Rumah Sakit Universitas Andalas
3.Fakultas Kedokteran Universitas Udayana
4.Fakultas Kedokteran Universitas Islam Negeri Syarif Hidayatullah
5.Fakultas Kedokteran Universitas Indonesia
6.Fakultas Kedokteran Universitas Mulawarman
1. DR. Dr. Bachti Alisjahbana, SpPDKPTI, MD, PhD.
2. Dr. Russilawati, SpP(K)
3. DR. Dr. I Made Susila Utama, SpPD KPTI FINASIM
4. Dr. Hari Hendarto, PhD, SpPD KEMD, FINASIM
5. DR. Dr. Erni Juwita Nelwan, SpPD, KPTI, FACP FINASIM, PhD
6. Dr. dr. Carta Agrawanto Gunawan, Sp.PD,KPTI, FINASIM
 Vaccine SARS-CoV-2 Fusion Protein Vaccine Approved 19-10-2021 Ongoing
91 Perbandingan Deksamethasone Dosis Tinggi Dan Dosis Standar Pada Anak Dengan Covid-19 Derajat Sedang Berat: Uji Klinis Acak Tersamar Ganda Multisenter (sterco Trial) III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
1.RSUPN Dr. Cipto Mangunkusumo
2.RSUP Dr. Hasan Sadikin
3.RSUP Dr. Kariadi
4.RSUD Dr. Soetomo
5.RSUD Dr. Moerwadi
1. Dr. dr. Nastiti Kaswandani,Sp.A(K)
2. dr. Diah Asri Wulandari, Sp.A(K)
3. dr. M. Syarofil Anam, Sp.A, Msi Med
4. Dr. dr. Retno Asih, Sp.A(K)
5. dr. Ismiranti Andarini, Sp.A
 Medicine Deksamethasone Approved 15-10-2021 Canceled
92 The Effect Of Incremental Continuous Ambulatory Peritoneal Dialysis On The Preservation Of Residual Kidney Function And Clinical Outcomes: A Randomized Controlled Trial (icodextrin) IV Local Prodia Diacro Laboratories
RSUPN Dr. Cipto Mangunkusumo
dr. Aida Lydia, PhD, SpPD,KGH
 Medicine Icodextrin Approved 08-10-2021 Prematurely Terminated
93 Efek Terapi Anti Interleukin-6 Tocilizumab Terhadap Outcome Pasien Covid-19 Derajat Berat III Local Balitbangkes, Kemenkes
RS Dustira, Cimahi
Dr. dr. Arief Kurniawan, SpAn, KIC, MMRS, FISQua
 Medicine Tocilizumab Approved 08-10-2021 Completed
94 "efikasi Dan Keamanan Imunoglobulin Intravena ( Ivig ) Pada Pasien Covid-19 Sedang Dan Berat" III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
1.RSUP Prof Dr. R. D. Kandou
2.RS. JH Awaloei
3.RS. Bethesda GMIM Tomohon
4.RS. Pancaran Kasih
5.RS. R. W. Mongisidi Teling
6.RS. Bhayangkara
1. Dr. dr. Diana Christine Lalenoh, SpAn,KNA, KAO, M.Kes
2. dr. Abraham B. Talumewo, MHSM
3. dr. Novia Rusli, Sp.PD
4. dr. Ray B C Rattu, Sp.PD, M.Kes
5. Kolonel ckm dr. I Gede Putu Arsana, Sp.PD
6. dr. Marlon Lumintang
 Biological Product IVIG Approved 04-10-2021 Canceled
95 Study To Compare Efficacy And Safety Of 8mg/kgbw And 4mg/kgbw Of Tocilizumab As Adjunctive Treatment Versus Standard Treatment In Severe Covid-19: Randomized Controlled, Open Label Trial III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUP Dr. Sardjito
dr. Ika Trisnawati Sp.PD,KP
Medicine Tocilizumab Approved 03-10-2021 Canceled
96 “effectiveness Of Novel Approaches To Radical Cure With Tafenoquine And Primaquine (effort)-a Randomized Controlled Trial In P. Vivax Patients” III Global Menzies School of Health Research Darwin (Royal Darwin Hospital Campus) John Mathews Building (JMB) / ALERT Asia Foundation
 PT. Equilab International
Puskesmas Labuhan Ruku, Kabupaten Batu Bara
dr. Ayodhia Pitaloka Pasaribu, M.Ked(Ped), Sp.A(K), Ph.D(CTM) 
 Medicine Tafenoquine, Primaquine Approved 13-09-2021 Ongoing
97 "efek Durasi Pemberian Remdesivir Terhadap Waktu Perbaikan Klinis Dan Keamanan Pada Pasien Covid-19 Usia Lanjut Derajat Sedang-berat'' III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUPN Dr. Cipto Mangunkusumo
Dr. dr. Kuntjoro Harimurti, SpPD,KGer, M.Sc.
 Medicine Remdesivir Approved 13-09-2021 Canceled
98 Phase I/ii, Placebo-controlled, Randomized, Double-blind, Dosefinding Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Adimrsc-2f Vaccine In Healthy Adolescents I/II Local Addimune Coorperation Taiwan
 PT IQVIA RDS Indonesia
RSA Universitas Gadjah mada
dr. Astari Pranindya Sari, M.Sc.,
 Vaccine Adimrsc-2f Approved 08-09-2021 Completed
99 Novation-1: A Randomized, Double-blind, Placebo-controlled, Phase Iii Study To Evaluate The Safety And Efficacy Of Aerosolized Novaferon + Soc Vs. Placebo + Soc In Hospitalized Adult Patients With Moderate To Severe Covid-19 III Global Genova Inc, China
IQVIA
1.RSUP Dr. Sardjito
2.RSUPN Dr. Cipto Mangunkusumo
3.RS Dr. M. Djamil
4.RS Udayana
1. Dr. Harik Firman Thahadian, Sp.PD, Ph.D
2. DR. Dr. Erni J. Nelwan, SpPD, KPTI, PhD
3. Dr. Irvan Medison, SpP(K), FISR, FAPSR
4. Dr. Cokorda Agung Wahyu Purnamasidhi, M. Biomed, SpPD
Medicine Novaferon Approved 30-08-2021 Canceled
100 Global, Multi-center, Randomized, Double-blind, Placebocontrolled, Phase Iii Clinical Study To Evaluate The Protective Efficacy, Safety And Immunogenicity Of Sars-cov-2 Messenger Ribonucleic Acid (mrna) Vaccine In Population Aged 18 Years And Older III Global PT Etana Biotechnologies Indonesia
 Tigermed Consulting Indonesia
Rumah Sakit Umum Pusat Persahabatan, Jakarta
a. RSPI Sulianti Saroso
b. Puskesmas Cilincing
c. Puskesmas Pulogadung
d. Puskesmas Ciracas
e. Puskesmas Duren Sawit
f. Puskesmas Cakung
g. Puskesmas Kalideres
h. Puskesmas Kebayoran Lama
Dr. dr. Erlina Burhan, MSc, SpP(K)
Vaccine Vaksin mRNA Approved 27-08-2021 Completed
101 A Randomized, Double-blind, Placebo-controlled, Multicenter Study Of Ensovibep (mp0420) In Ambulatory Adult Patients With Sym-ptomatic Covid-19 (the “empathy” Trial) III Global Molecular Partners AG
 PT IQVIA
1.RS Akademik UGM
2.RS Paru Dr. M Goenawan Partowidigdo
3.RS Murni Teguh Medan
4.RS Abdul Radjak Salemba
1. Dr. Maria Erika Pranasakti, Sp.PD
2. Dr. Alvin Kosasih, Sp.P(K), MKM, FISR, FAPSR
3. Dr. Ayodhia P. Pasaribu, M.Ked(PED), Sp.A(K), PhD
4. Dr. Satria Pratama, Sp.P
Medicine Ensovibep (MP0420) Approved 25-08-2021 Prematurely Terminated
102 Studi Efikasi Dan Keamanan Terapi Intravenous Imunoglobulin Pada Pasien Covid-19 Derajat Berat Dibandingkan Standard Of Care III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSPI Prof. Dr. Sulianti Saroso
dr. Adiatmo Pratomo, Sp.PD
Biological Product IVIG Approved 27-07-2021 Canceled
103 Efikasi Dan Keamanan Remdesivir Pada Pasien Covid 19 Derajat Sedang Berat Di Rsup Dr. M.djamil III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUP Dr. M. Djamil Padang
dr. H. Irvan Medison, SpPK, FIRS, FAPSR
Medicine Remdesivir Approved 21-07-2021 Canceled
104 Intravenous Immunoglobulin (ivig) Sebagai Terapi Pasien Covid-19: Sebuah Uji Klinis III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUD Dr. Moh Hoesin Palembang
a. RSUP Dr Rifai Abdullah
b. RSUD Siti Fatimah
c. RSUD BARI Palembang
d. RSUD Charitas Palembang
e. RSU Siloam Sriwijaya
f. RS Hermina Palembang
g. RS Hermina OPI Banyuasin
dr Agustina br Haloho, SpAn(K), M,Kes
 Biological Product IVIG Approved 12-07-2021 Canceled
105 A Global Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Iii Clinical Trial To Evaluate The Efficacy, Safety, And Immunogenicity Of Recombinant Covid-19 Vaccine (sf9 Cells), For The Prevention Of Covid-19 In Adults Aged 18 Years And Older III Global 1.WestVac Biopharma Co., Ltd
2.West China Hospital of Sichuan University
 PT Equilab International
1.Rumah Sakit Umum Persahabatan
a. RS Permata Bekasi
b. RSAU dr. Esnawan Antariksa
c. RS Khusus Daerah Duren Sawit
d. Puskesmas Ciketingudik
e. RS Pusat Pertamina
2.RS Universitas Airlangga
1. Dr. Sita Andarini, SpP(K). PhD
2. Prof. Dr. Nasronudin, dr., SpPD., KPTI., FINASIM
 Vaccine Vaksin SF9 Approved 07-07-2021 Ongoing
106 A Phase 2/3, Randomized, Double-blinded, Placebo-controlled Study To Evaluate The Efficacy, Safety, And Immunogenicity Of Gx-19n, A Covid-19 Preventive Dna Vaccine In Healthy Individuals II/III Global PT Kalbe Farma
Fakultas Kedokteran – Universitas Indonesia
Prof. Dr. dr. Iris Rengganis, Sp.PD,KAI, FINASIM
Vaccine GX-19N Approved 05-07-2021 Canceled
107 Safety And Immunogenicity Of covid-19 vaccine In Healthy Adults Aged 60 Years And Above In Indonesia III Local PT. Bio Farma
Departemen Ilmu Kesehatan Anak FK Universitas Airlangga - RSUD Dr. Soetomo
Dr. Dominicus Husada, dr., SpA(K)
 Vaccine Sinovac Canceled 01-07-2021
108 Uji Klinik Fase Ii-iii, Acak, Tersamar Ganda Dengan Kontrol Plasebo Untuk Menilai Keamanan Dan Efikasi Pemberian Oral Ivermectin Pada Pasien Covid-19 Ringan Sedang Yang Di Rawat Di Rumah Sakit II/III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
1.RSUD dr. Soedarso
2.RSUP H. Adam Malik
3.FK Militer, UNHAN
4.RSUP Persahabatan
5.RSUP Prof. Dr.Sulianti Saroso
1. Dr. dr. Pinda Hutajulu, Sp.OG(K) FER
2. Dr. dr. Bintang Yinke Magdalena Sinaga, M.Ked(Paru)., Sp.P(K)
3. Brigjen TNI Dr. dr. Soroy Lardo, Sp.PD,KPTI, FINASIM
4. dr. Budhi Antariksa, Ph.D, Sp.P(K)
5. dr. Pompini Agustina Sitompul, SpP(K)
Medicine Ivermectin Approved 27-06-2021 Prematurely Terminated
109 The Use Of Systemic Corticosteroids In Moderate To Critical Ill Patients With Covid-19 III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RS Soetomo, Surabaya
dr Irmi Syafa'ah, Sp.P(K)
 Medicine Dexamethasone Approved 21-06-2021 Canceled
110 Uji Klinik Acak Tersamar Ganda Untuk Membandingkan Efikasi Pemberian Remdesivir 5 Dan 10 Hari Pada Pasien Covid-19 Rawat Inap Derajat Sedang Dan Berat” Atau Disingkat Covid Remisi III Local Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUP Persahabatan
Dr. dr. Erlina Burhan, MSc, SpP(K)
Medicine Remdesivir Approved 21-06-2021 Canceled
111 Uji Klinik Kegunaan Dan Keamanan Terapi Exosome-msc (eksosom Yang Diproses Dari Sel Punca Mesenkimal) Untuk Meredakan Hiperinflamasi Pada Pasien Covid-19 I Local Kementrian Riset dan Teknologi Badan Riset dan Inovasi Nasional
 PT Equilab International
RSUP Dr. Sardjito Yogyakarta
 Dr. dr. A. Bambang Darwono Sp.B, SpOT(K), FICS

Dr. Med.Dr Indwiani Astuti
 Biological Product Exosome-MSC Approved 18-06-2021 Prematurely Terminated
112 Safety Profile Following Inactivated Covid-19 Vaccine In Healthy Adults Aged >18 Years In Indonesia IV Local PT Bio Farma
Puskesmas di Jakarta
Dr. Julitasari Sundoro, dr., MSc-PH
 Vaccine Inactivated Covid-19 Vaccine Approved 02-06-2021
113 Uji Klinik Kegunaan Dan Keamanan Terapi Exosome-msc (eksosom Yang Diproses Dari Sel Punca Mesenkimal) Untuk Meredakan Hiperinflamasi Pada Pasien Covid-19 I Local Kementrian Riset dan Teknologi Badan Riset dan Inovasi Nasional
 PT Equilab International
1.RSPAD Gatot Subroto
2.RSUP Dr. M. Djamil, Padang
 Prof. dr. Ali Ghufron Mukti, M.Sc., Ph.D

1. dr. Maria C. H. Winurti, Sp.P
2. dr. Fenty Anggrainy, Sp.P(K), FAPSR
 Biological Product Exosome-MSC Approved 08-03-2021 Prematurely Terminated
114 A Phase 1/2a, Multi-center, Randomized, Double-blind, Placebo-controlled Study To Investigate The Safety, Tolerability, And Immunogenicity Of Gx-19, A Covid-19 Preventive Dna Vaccine In Healthy Subjects 2 I/II Global PT Kalbe Farma, Tbk
RSUPN Dr. Cipto Mangunkusumo
Prof. Dr. Dr. Iris Rengganis, SpPD-KAI
 Vaccine GX-19 PLASMA DNA Canceled 26-02-2021
115 Serological Screen And Treat Trial For P.vivax : A-proof Of-conce-pt Trial In Eastern Indonesia III Local Walter and Eliza Hall Institute / University Of Oxford
 EOCRU (EIJKMAN Oxford Clinical Research Unit)
Departemen Parasitologi, Fakultas Kedokteran Universitas Indonesia
Prof. Dr. dr. Inge Sutanto, MPhil, SpPARK,
Medicine Approved 23-02-2021
116 Randomised Evaluation Of Covid-19 Therapy (recovery) III Local University of Oxford
 Eijkman-Oxford Clinical Research Unit
1.RS Metropolitan Medical Center (MMC), Jakarta
2.RS Marta Friska, Medan
 Dr. dr. Erni Juwita Nelwan, SpPD,KPTI,FACP FINASIM, PhD

1. dr. Sandhi Prabowo, Sp.An KIC
2. dr. Fransiscus Ginting, M.Ked., SpPD, KPTI
 Medicine Colcisin, Dexamethasone, Empaglifozine Approved 18-02-2021 Ongoing
117 A Phase Iii Randomized, Double-blind, Placebo-controlled Clinical Trial In 18 Years Of Age And Above To Determine The Safety And Efficacy Of Zf2001, A Recombinant Novel Coronavirus Vaccine (cho Cell) For Prevention Of Covid-19” III Local Anhui Zhifei Longcom Biopharmaceutical Co., Ltd (Sponsor)
 PT Prodia Diacro Laboratories
1.Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Indonesia
2.Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Padjajaran
1. Prof. Dr. dr. Hindra Irawan Satari, Sp.A(K), MTropPaed
2. Dr. Rodman Tarigan, Sp.A (K), MKes
 Vaccine Vaksin Zifivax Approved 03-02-2021 Completed
118 Efficacy And Safety Of Normoxic Allogenic Umbilical Cord Mesenchymal Stem Cells Administered As Adjunctive Treatment To Standard Treatment In Severe Patients With Covid-19 II/III Local 1.PT. Bifarma Adiluhung
2.Kemenristek BRIN
1.RSUD Dr. Moewardi
2.RSUP Dr. Sardjito
3.RSUP Dr. Hasan Sadikin
1. Dr.dr. Arief Nurudhin, SpPD, KR, FINASIM
2. Prof. DR. Dr. Samekto Wibowo, P.Far, K,Sp.FK(K), SpS(K)
3. Dr. Ahmad Faried, SP.BS(K), Ph.D
 Biological Product UCMSC Approved 30-12-2020
119 A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Administration Study To Evaluate The Safety And Efficacy Of Gx-i7 In Elderly Patient With Asymptomatic Or Mild Symptoms Of Severe Acute Respiratory Syndorome Coronavirus (sars-cov-2) Infection II Global 1.Genexine, Inc. Korea
2.PT Kalbe Genexine Biologics
1.RSUP Persahabatan
2.RS Mitra Keluarga Kelapa Gading
1. Dr. dr. Erlina Burhan, MSc, Sp.P (K)
2. Dr. Frans Liwang, Sp.PD
 Biological Product GX I7 Approved 29-12-2020
120 Studi Efektivitas Dan Keamanan Kuinin Sulfat Pada Subjek Dewasa Penderita Covid-19 Yang Dirawat Di Rumah Sakit : Sebuah Studi Adaptif, Multicenter, Acak, Tersamar Ganda, Terkontrol III Local Kementerian Riset dan Teknologi BRIN
 PT. Prodia DiaCRO Laboratories
1.RS Universitas Indonesia
2.RSPAD Gatot Soebroto
3.RSUP Dr. Hasan Sadikin
1. dr. Raden Rara Diah Handayani, Sp.P(K).
2. dr. Dewiyana Andari Kusmana, Sp.P
3. dr. Iceu Dimas Kulsum, Sp.PD, Sp.P
 Medicine Kuinin Sulfat Approved 10-12-2020
121 An International Multicenter, Adaptive, Randomized Double-blind, Placebo-controlled Trial Of The Safety, Tolerability And Efficacy Of Anti Coronavirus Hyperimmune Intravenous Immunoglobulin For The Treatment Of Adult Hospitalized Patients At Onset Of Clinical Progression Of Covid19” Short Title: Inpatient Treatment With Anti-coronavirus Immunoglobulin (itac) - Protocol No: Insight 013 II Global 1.Institute of Allergy and Infectious Disease (NIAID), National Institute of Health (NIH), Amerika
2.Puslitbang Sumber Daya dan Pelayanan Kesehatan, Balitbang Kesehatan, Kemenkes RI
1.RSUPN Dr. Cipto Mangunkusumo
2.RSUD Dr. Soetomo
3.RSUD Kabupaten Tangerang
1. dr. Adityo SpPD, K-PTI
2. Prof. dr. Usman Hadi, Ph.D, SpPD, K-PTI
3. dr. Prasetyo Hariadi, SpP
 Biological Product Anticoronavirus Immunoglobulin Approved 08-12-2020
122 Uji Klinik Adaptif Fase I Vaksin Yang Berasal Dari Sel Dendritik Autolog Yang Sebelumnya Diinkubasi Dengan Spike Protein Severe Acute Respiratory Syndrome Coronavirus-2 ( Sars-cov-2) Pada Subjek Yang Tidak Terinfeksi Covid-19 Dan Tidak Terdapat Antibodi Anti Sars-cov-2 I Local 1.PT. AIVITA Biomedika Indonesia
2.Badan Penelitian dan Pengembangan Kesehatan
RSUP Dr. Kariadi
Dr.dr. Muchlis Achsan Udji, SpPD-KPTI, FINASIM
 Biological Product Sel Dendritik Approved 02-12-2020
123 A Multi Center, Randomized, Double-blind, Parallel Design, Phase 2 Study To Evaluate The Efficacy And Safety Of Hzvsf-v13 Compared To Standard Of Care After Intravenous (iv) Administration With Add-on Standard Of Care In Covid-19 Moderate To Severe Patients II Global ImmuneMed Inc, Korea Selatan
 PT. Prodia Diacro Laboratories
1.RSUP Persahabatan
2.RSUD Pasar Minggu
3.RS Pusat Pertamina
 Dr. dr. Erlina Burhan, MSc, Sp.P (K)

1. Dr. dr. Erlina Burhan, MSc, Sp.P (K)
2. dr. Sri Dhuny Atas Asri, Sp.P
3. dr. Wahyuningsih Suharno, Sp.P
 Biological Product hzVSFv13 Approved 01-12-2020
124 A Randomized, Double-blind, Multicenter, Phase Iii Clinical Study Of Hlx10 (recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (carboplatin Nanoparticle Albumin Bound(nab)-paclitaxel) Vs Chemotherapy (carboplatin Nab-paclitaxel) As Firstline Therapy For Locally Advanced Or Metastatic Squamous Non Small Cell Lung Cancer (nsclc) III Global Shanghai Henlius Biotech
 *PT. Prodia Diacro Laboratories
1.RSUD Dr. Saiful Anwar
2.RS Kanker Dharmais
1. Dr. Arif Riswahyudi Hanafi, SpP(K)
2. Dr. Suryanti Dwi Pratiwi, SpP(K), FISR, FAPSR
 Biological Product HLX-10 Approved 01-12-2020
125 Evaluasi Pemberian Remdesivir Pada Pasien Covid-19 Di Rsup Persahabatan Jakarta III Local PT. Amarox Pharma Global
RSUP Persahabatan
Dr. dr. Erlina Burhan, MSc, Sp.P (K)
 Medicine Remdesivir Approved 01-12-2020
126 Persistence And Long Term Protection Of Vi Antibodies Induced By Vi-dt Conjugate Vaccines In Indonesian Adults, Adolescents, Children And Infants II Local PT. Bio Farma
Departemen Ilmu Kesehatan Anak FK Universitas Indonesia
a. Puskesmas Jatinegara
b. Puskesmas Senen
dr. Bernie Endyarni Medise, SpA(K), MPH
 Vaccine Vi-DT Conjugate Approved 10-11-2020
127 Efficacy, Safety Dan Immunogenecity Of Rotavirus Rv3 Vaccine(biofarma) In Neonates, Lot To Lot Consistency And Antigen Interference With Co-administeres Epi Vaccines III Local PT. Bio Farma
 IQVIA Indonesia
Center for Child Health Universitas Gadjah Mada
 dr. Jarir At-Thobari, PhD

Dr.dr. Titis Widowati, Sp.A(K)
 Vaccine Rotavirus Approved 07-10-2020
128 Fase Iii, Acak – Terbuka, Uji Klinis Efikasi Dan Keamanan Favipiravir Pada Pasien Covid-19 Di Indonesia III Local Pusat Penelitian dan Pengembangan Sumber Daya dan Pelayanan Kesehatan, BKPK Kemenkes
1.RSPI Sulianti Saroso, Jakarta
2.RSJ Soeradjo, Magelang
3.RSUP Dr Karyadi, Semarang
Dr. dr. Armedy Ronny Hasugian, M.Biomed

1. dr.Adria Rusli, SpP(K)
2. dr. Harli Amir Mahmudji, SpPD, KEMD
3. dr. Sofyan, SpP(K)
 Medicine Favipiravir Approved 07-10-2020
129 A Multicenter, Adaptive, Randomized Blinded Controlled Trial Of The Safety And Efficacy Of Investigational Therapeutics For The Treatment Of Covid-19 In Hospitalized Adults” (adaptive Covid-19 Treatment Trial/ Actt Study) III Global INA-RESPOND
1.RSUP Persahabatan
2.RSU Kab Tangerang
1. Dr. Erlina Burhan, MSc, PhD, Sp.P(K)
2. dr. Prasetyo Hariadi, SpP
 Medicine Remdesivir Canceled 29-09-2020
130 Keamanan Dan Imunigenitas Vaksin Inactivated Sars-cov-2 Pada Orang Sehat Berumur >= 6 Tahun I Global Badan Penelitian dan Pengembangan Kesehatan Kemenkes RI
RS Fatmawati
Dr. dr. Irmansyah, Sp.KJ(K)
 Vaccine Sinopharm Canceled 29-09-2020
131 Reducing The Risk Of Plasmodium Vivax Relapse After Acute Plasmodium Falciparum Malaria In Co-endemic Areas - A Randomized Controlled Trial (prima) III Local Menzies School of Health Research, Australia
 EIJKMAN-Oxford Clinical Research Unit
FK Universitas Indonesia
a. Puskesmas Mangili
Prof. dr. Inge Sutanto, MPhil, SpPar(K)
 Medicine Primaquine Approved 28-09-2020
132 Efficacy, Safety Dan Immunogenecity Of Rotavirus Rv3 Vaccine(biofarma) In Neonates, Lot To Lot Consistency And Antigen Interference With Co-administeres Epi Vaccines III Local PT. Bio Farma
 IQVIA Indonesia
Pediatric Reserach Center Universitas Sebelas Maret
 dr. Jarir At-Thobari, PhD

dr. Hary Wahyu N, M.Kes., Sp.A(K)
 Vaccine Rotavirus Approved 18-09-2020
133 Aplikasi Sel Punca Mesenkimal Asal Tali Pusat Sebagai Terapi Adjuvan Pada Pasien Pneumonia Covid-19 Kritis III Local PT. Kimia Farma
1.RSPI Sulianti Saroso, Jakarta
2.RSUPN Dr. Cipto Mangunkusumo, Jakarta
3.RS Persahabatan, Jakarta
4.RS Universitas Indonesia, Jakarta
5.RSUD Dr. Soetomo, Surabaya
6.RS Universitas Airlangga, Surabaya
 Prof. Dr. dr. Ismail Hadisoebroto Dilogo, Sp.OT(K)

1. Dr. Pompini Agustina S, Sp.P(K)
2. Dr. dr. Dita Aditianingsih, Sp-An-KIC
3. DR. dr. Erlina Burhan, MSc, Sp.P (K)
4. Dr. dr. Dita Aditianingsih, Sp-An-KIC
5. Dr. Bambang Pujo SpAn.KIC
6. Dr. Bambang Pujo SpAn.KIC
 Biological Product Sel Punca Mesenkimal Approved 13-08-2020
134 High Dose Oral Rifampicin To Improve From Adult Tuberculosis Meningitis (harvest) III Local Infectious Disease Institute Limited, Uganda
1.RSUP Dr. Hasan Sadikin
2.RSUPN Dr. Cipto Mangunkusumo
1. dr. Ahmad Rizal Ganiem, Sp.S(K), PhD
2. dr. Darma Imran, SpS(K)
 Medicine Rifampicin Approved 03-08-2020
135 A Phase Iii, Observer-blind, Randomized, Placebo-controlled Study Of The Efficacy, Safety And Immunogenicity Of Sars-cov-2 Inactivated Vaccine In Healthy Adults Aged 18-59 Years In Indonesia III Local PT. Bio Farma
RSUP Dr. Hasan Sadikin-FK Unpad
Prof. Dr. Kusnandi Rusmil, dr., Sp.A(K)., MM
 Vaccine Sinovac Approved 27-07-2020
136 Studi Terapeutik Evaluasi Efikasi Dan Keamanan Dw-msc Pada Pasien Covid-19: Studi Acak, Tersamar Ganda, Dan Terkontrol Plasebo I/II Local PT. Daewoong Infion
RSUP Dr. Wahidin Sudirohusodo, Makassar
dr. Irawaty Djaharuddin, Sp.P (K)
 Biological Product DW-MSC Approved 24-07-2020
137 Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan Covid 19 II/III Local BKPK Kemenkes RI
28 Rumah Sakit
Prof. David Hanjono Muljono, SpPD, PhD
 Biological Product Plasma convalescent Approved 20-07-2020
138 Chloroquine/ Hydroxychloroquine Prevention Of Coronavirus Disease (covid-19) In The Healthcare Setting; A Randomised, Placebo-controlled Prophylaxis Study (copcov) III Local University Of Oxford
 EIJKMAN-Oxford Clinical Research Unit
1.RSUP Dr. Cipto Mangunkusumo
2.RSUP Persahabatan
 Dr. dr. Erni Juwita Nelwan, SpPD,K-PTI,FACP-FINASIM, PhD

1. Dr. dr. C. Martin Rumende, Sp.PD-KP dan Dr. Robert Sinto, Sp.PD, K-PTI
2. Dr. dr. Erlina Burhan, Sp.P
 Medicine Chloroquine/Hydroxychloroquine Approved 15-07-2020
139 Uji Klinik Fase Iii, Multisenter, Acak Terkontrol, Membandingkan Efikasi Dan Keamanan Kombinasi Lopinavir/ritonavir-azythromycin, Lopinavir/ritonavir-doxycycline Dan Hydroxychloroquin–azythromycin Dengan Terapi Standar Pada Pasien Covid-19 Yang Dirawat Di Rumah Sakit Dengan Derajat Ringan, Sedang, Dan Berat Yang Tidak Menggunakan Ventilator III Local Badan Intelijen Negara (BIN)
RS UNAIR, RSPAD Gatot Subroto, RSUD Bhakti Dharma Husada, RSUD Soewandi, Gd. Isolasi Covid Lamongan, RSUD Kediri
Dr. Purwati, dr., Sp.PD., FINASIM.
 Medicine Kombinasi Approved 03-07-2020
140 Penilaian Efikasi Dan Keamanan Injeksi Bdb-001 Untuk Pengobatan Covid 19 Dengan Pneumonia Berat Dan Progresif , Suatu Uji Klinik Fase Ii Add On Pada Terapi Konvensional , Paralel, Acak Dan Terbuka II Global Staidson (Beijing) Biopharmaceutical Co., Ltd
 PT Etana Biotechnologies Indonesia
1.RSUP Persahabatan
2.RSUD Pasar Minggu
3.RSUD Cengkareng
1. dr. Erlina Burhann, M.Sc, SpJP(K)
2. dr. Sri Dhuny Atas Asri, Sp.P, FISR
3. dr. Puji Astuti, SpP
 Medicine BDB-001 Approved 15-06-2020
141 Efficacy And Safety Of Convalescent Plasma Transfusion Administered As Adjunctive Treatment To Standard Treatment In Moderate, Severe, And/or Critically Ill Patients With Covid19 III Local Kementerian Riset dan Teknologi BRIN
1.RSUP Dr. Syaiful Anwar
2.RSUP Dr. Sardjito
3.RSUD Dr. Soetomo
4.RS UNAIR
5.RSUP Dr. Soeradji Tirtonegoro
6.RSPI Sulianti Saroso
7.RSUD Dr. Moewardi
8.RSUP Dr. Kariadi
9.RSUP Dr. M.Djamil
10.RSUP Dr. Wahidin Sudirohusodo
 Dr. Jarir At Thobari, Dpharm, PhD

1. Dr. Putu Moda A, SpPD, K-Med
2. Dr. Johan Kurnianda, SpD-KHOM
3. Dr. Bambang Pujo Semedi, SpAN.KIC
4. Dr. Hamzah, SpAn, KNA
5. Dr. Achmad Thabrani, Sp.PD
6. Dr. Adiatmo Pratomo, SpPD
7. Dr. Jatu Aphridasari, Sp.P(K)
8. DR. dr. Santosa, SpD-KHOM
9. Dr.dr.Iza Wahid, SpPD-KHOM
10. Dr. Faisal Muchtar, SpAn. KIC
Biological Product Plasma convalescent Approved 11-05-2020
142 Comparison Of Immunogenicity And Safety Of Dtp Hb Hib (biofarma) With Pentabio Vaccine Primed With Recombinant Hepatitis B At Birth Dose(using Different Source Of Hepatitis B) In Indonesian Infants III Local PT. Bio Farma
FK Universitas Padjadjaran - RS Hasan Sadikin
Dr. Eddy Fadlyana, dr., Sp.A(K)., M.Kes
 Vaccine DPT HB Hib Approved 13-04-2020
143 Uji Klinik Favipiravir (avigan) Untuk Pengobatan Pada Pasien Covid 19 Di Beberapa Rumah Sakit Rujukan Covid 19 Di Jakarta III Local PT. Pertamina Bina Medika IHC
1.RSUP Dr. Cipto Mangunkusumo
2.RSUP Persahabatan
3.RS Pertamina Jaya
4.RS Pusat Pertamina
5.RS PELNI
6.RSPI Sulianti Suroso
7.RSPAD Gatot Subroto
Dr.Dante Saksono HHarbuwono, SpPD-KMED,PhD

1. Dr. Martin Rumenda , Sp.PD, KP, FINASIM, FCCP ; Dr. Adityo Susilo, Sp.PD, KPTi
2. Dr. Erlina Burhan , SpP(K), M.Sc.,PhD
3. Dr. Nyoman Sp.P
4. Dr. Wayu, Sp.P
5. Dr Robert Sinto, Sp.PD ; Dr. Erlang Samoedra, SpPD; Dr. Prasenohadi, Sp. P-KIC, PhD
6. Dr. Pompini, SpP
7. Dr. Retno Wihastuti, SpP
 Medicine Favipiravir Approved 10-04-2020
144 An International Randomise Trial Of Additional Treatments For Covid 19 In Hospital Patients Who Are All Receiving The Local Standard Of Care (solidarity Trial) III Global 1.WHO
2.Badan Penelitian dan Pengembangan Kesehatan, Kemenkes RI
1.RS Kandou Manado
2.RS Udayana
3.RS Wahidin Suroso
4.RSUD Ambarawa
5.RS Dr. M. Djamil
6.RSPI Sulianti Suroso
7.RSUD Kariadi Semarang
8.RSUD Soetomo
9.RSUD Dr. Hasan Sadikin
10.RSJ Prof Dr. Soerojo
 Dr.dr.Irmansyah, Sp.KJ(K) dan Prof.dr, Menaldi Rasmin, Sp.P(K)

1. dr. Agung Nugroho, SpPD-KPTI
2. Dr. dr. Agus Somnia, SpPD-KPTI
3. Dr.dr Irawaty Djaharuddin, Sp.P(K)
4. dr. Hayu Arya Ratna Taufiqi, SpP
5. dr. Irvan Medison, SpP
6. dr. Pompimi Agustina Sitompul, SpP(K)
7. dr. Sofyan Budi Rahardjo, Sp.P(K)
8. Dr.dr. Soedarsomo, SpPK(K)
9. dr. Yovita Hartantri, SpPD-KPTI(K)
10. dr. Harli Amir Mahmudi, SpPD
 Medicine Solidarity Trial Approved 05-04-2020
145 Dosisi Tinggi Rifampisin 2 Bulan Versus Dosis Standar Rifampisin 4 Bulan Untuk Pengobatan Infeksi Laten Tb (iltb) : Sebuah Uji Klinik (2r2) II Local McGill International TB Centre, Canada
RS Pendidikan Universitas Padjajaran
Prof. Rovina Ruslami., dr., SpPD, PhD
 Medicine Rifampicin Approved 16-03-2020 Completed
146 Open Label Randomised Controlled Trial Of Efepoetin Alfa For Treatment Of Anaemia Associated With Chronic Kidney Disease Patients Not On Dialysis (nd-ckd). A Non Inferiority Trial Compared To Methoxy Polyethylene Glycol-epoetin Beta (mircera) III Global PT. Kalbe Genexine Biologics
1.RS PGI Cikini
2.RS Islam Jakarta, Cempaka Putih
3.RS Islam Jakarta Pondok Kopi
4.RSUP Fatmawati
5.RSUPN Dr. Cipto Mangunkusumo
1. Dr. Tunggul D. Situmorang, SpPD-KGH
2. Dr. Kuspudji Dwitanto R, SpPD-KGH
3. Dr. Kuspudji Dwitanto R, SpPD-KGH
4. Dr. J Sarwono, SpPD-KGH
5. Dr. Pringgodigdo Nugroho, SpPD-KGH
 Biological Product Efepoetin Alfa Approved 13-03-2020
147 A Randomized Double Blind Controlled Clinical Study To Evaluate Efficacy And Safety Of Diclofenac With Heparin (diclofenac Sodium 1 % And Heparin 200 Iu W/w) Gel Compared To Gel Contained Diclofenac Sodium 1% Only And Heparin 200 Iu W/w Only In Subjects With Acute Blunt Soft Tissue Injuries III Local PT. Tunggal Idaman Abdi
 PT. Equilab International
Pusat Pelatihan Olahraga Pelajar (PPOP) Clinic
a. Indonesia Sports Medicine Centre (ISMC)
dr. Zeth Boroh, Sp.KO
 Medicine Diclofenac + Heparin Approved 09-03-2020
148 A Dose Escalation Evaluation Of Safety And Tolerability And Pharmacokinetics Of Adrecizumab – A Humanized Monoclonal Antibody Against Adrenomedullin (adm) In Patients With Acute Heart Failure Requiring Hospitalization” Adrecizumab Dose Escalation Safety And Tolerability Evaluation (adeste) II Global Great Network Italy
 PT. Prodia Diacro Laboratories
RSUP Dr. Sardjito
dr. Anggoro Budi Hartono , M.Sc., Ph,D,
Biological Product Adrecizumab Approved 09-03-2020
149 Immunogenicity And Safety Of Vi-dt Typhoid Conjugate Vaccine (bio Farma) In Adults,children And Infants, Lot To Lot Consistency, Noninferiority To Pqed Tcv And Typhoidvi Polysaccharide Vaccine (phase Iii) III Local PT Bio Farma
 PT Prodia Diacro Laboratories
1.Departemen Ilmu Kesehatan Anak FK Universitas Indonesia
2.Departemen Ilmu Kesehatan Anak FK Universitas Airlangga - RS Soetomo
3.Departemen Ilmu Kesehatan Anak FK Universitas Udayana - RS Sanglah
1. dr. Bernie Endyarnie Medise, Sp A(K), MPH
2. Dr. Dominicus Husada, dr., Sp.A(K)
3. Dr. I Gusti Ayu Trisna Windiani, dr., Sp.A(K)
 Vaccine Typhoid Conjugate Vaccine Approved 20-01-2020
150 A Prospective , Randomized, Active Treatment - Controlled, Evaluator Blinded (radiologist Reviewer And Physician Evaluator) Multicenter Study To Establish The Superiority Of A Hyaluronan - Based Scaffold (hyalofast) With Autologous Bone Marrow Aspirate Concentrate (bmac) In The Treatment Of Articular Knee Cartilage Defect Lesions In Comparison To Control (microfracture Treatment) II Global Ani Therapeutics US America
PT. Pharma Metrics
1.RS Medistra
2.RS Royal Progress
1. Dr.dr. Andri Maruli TuaLubis., SpOT(K)
2. dr. Bobby N.Nelwan, SpOT
Medicine Hyalofast Approved 06-01-2020
151 The Efficacy, Safety, And Immunogenecity Study Comparing An Insulin Glargine Biosimilar Sansulin Log-g With Its Reference Lantus In Patients With Type 2 Diabetes Melitus IV Local PT. Sanbe Farma
1.Rumah Sakit Pelni
2.RS Islam Jakarta Pondok Kopi
3.RSUD Pasar Rebo
1. dr. Tri Juli Edi Tarigan, SpPD-KEMD
2. dr. Khomimah, SpPD-KEMD
3. dr. Teddy Ervano, SpPD
 Biological Product Sansulin Approved 20-12-2019
152 Efficacy And Safety Of Peg 3350 For Treatment Of Chronic Constipation I Local PT. Meiji Indonesia Pharmaceutical Industries
RSUPN Dr. Cipto Mangunkusumo
Prof. Dr, dr. Murdani Abdullah, SpPD-KGEH
 Medicine Macrogol 3350/ PEG Approved 28-11-2019
153 Safety And Preliminary Of Immunogenicity Following Recombinant Hepatitis B (biofarma) Vaccine In Adults & Children I Local PT. Bio Farma
RSUP Dr. Hasan Sadikin
Prof. Dr. Kusnandi Rusmil, dr., Sp.A(K)., MM
 Vaccine Vaksin Hepatitis Approved 18-11-2019 Completed
154 Studi Klinis Untuk Mengevaluasi Keamanan Dan Efikasi Dari Epodion Pada Pasien Pgk(penyakit Ginjal Kronis) : Uji Klinis Label Terbuka, Teracak, Komparasi Obat Aktif, Desain Paralel Dan Multi Sentral IV Local Daewoong Pharmaceutical., Co., Ltd
 PT. Equilab International
RSPAD Gatot Soebroto
dr. Jonny Sp.PD-KGH,M.Kes, MM
 Biological Product Epodion Approved 18-11-2019
155 Pharmacodynamic Equivalence Of Ovine Enoxaparin To Porcine Enoxaparin (lovenox®) In Healthy Volunteers I Local PT. Metiska Farma
PT. Pharma Metric Labs
Prof. Arini Setiawati, PhD
 Medicine Ovine Enoxaparin Approved 19-08-2019 Completed
156 Non Interventional Study On Effectiveness And Safety Of Fixed Dose Combination Of Netupitant And Palonesetron (nepa)in Chemotherapy - Induced Nausea And Vomiting (cinv) Patients Receiving Moderately (mec) Or Highly Emetogenic Chemotherapy (hec) (aky18-id-401) IV Local Mundipharma Laboratories GmBH
 PT. Prodia Diacro Laboratories
Rumah Sakit Kanker Dharmais
Dr.dr.Hilman Tadjoedin, SpPD-KHOM
 Medicine NEPA Approved 19-08-2019
157 Immunogenicity & Safety Of Bio Farma’s Measles-rubella (mr) Vaccine In Indonesian Infants (bridging Study) III Global PT Bio Farma
RSUD Dr. Soetomo
Dr. dr. Dominicus Husada, SpA(K)
 Vaccine Measles-Rubella (MR) Vaccine Approved 19-08-2019
158 A Phase Iiib Randomised Open Label Trial To Complete Dolutegravir With Pharmaco Enhanched Darunavir Versus Dolutegravir With Predertemined Nucleosides Versus Recommended Standard Of Care Antiretrovial Regimens In Patients With Hiv -1 Infection Who Have Failed Recommended First Line Theraphy III Global University of New South Wales, Australia
 INA- RESPOND
1.RSUPN Dr. Cipto Mangunkusumo
2.RSUD Dr. Soetomo
3.RSUP Wahidin Sudirohusodo
4.RSUP Dr. Sardjito
1. Dr. dr. Evy Yunihastuti, Sp.PD-KAI FINASIM
2. Prof. dr. Usman Hadi, PhD., Sp.PD-KPTI
3. dr. Sudirman Katu, Sp.PD-KPTI
4. Dr. Yanri Wijayanti Subronto, Ph.D.Sp.PD-KPTI, FINASIM
 Medicine Dolutegravir Approved 12-08-2019
159 Protectivity And Safety Following Recombinant Hepatitis B Vaccine With Different Source Of Hepaitis B Bulk Compared To Hepatitis B (bio Farma) Vaccine In Indonesia Population II Local PT. Bio Farma
Fakultas Kedokteran Universitas Diponegoro
Dr. Yetty Movieta Nency Sp.AK
 Vaccine Vaksin Hepatitis B Approved 18-07-2019 Completed
160 A Dose Escalation Evaluation Of Safety And Tolerability And Pharmacokinetics Of Adrecizumab – A Humanized Monoclonal Antibody Against Adrenomedullin (adm) In Patients With Acute Heart Failure Requiring Hospitalization” Adrecizumab Dose Escalation Safety And Tolerability Evaluation (adeste) II Global Great Network Italy
 PT. Prodia DiaCRO Laboratories
RS Saiful Anwar
Dr. M. Saifur Rohman, SpJP(K)., Ph.D
 Biological Product Adrecizumab Approved 08-07-2019
161 Phase 3 Study Of Sfpp In Knee Osteoarthritis : A Randomized Controlled Study Using Diclofenac Gel As The Comparator III Local Taisho Pharmaceutical Co. Ltd. Jepang
 PT. Prodia Diacro Laboratories
1.RSUD Dr. Soetomo
2.RS TNI AU Soemitro
3.RSUD Dr. Saiful Anwar
4.Klinik Reumatologi dan Alergi, Malang
1. Dr. Yuliasih, SpPD-KR
2. Dr. Lita Diah Rahmawati, SpPd-KR
3. Dr. Cesarius Singgih Wahono, SpPD-KR
4. Prof. Handono Kalim, SpPD-KR
 Medicine S-Flurbiprofen Plaster (SFPP) Approved 10-06-2019
162 Short Intervention And Measurement Of Pk Of Linezolid In Tb Meningitis (simple) II Global Radboud University Medical Center, Nijmegen, Belanda
Fakultas Kedokteran Universitas Padjajaran – RSUP Dr. Hasan Sadikin
dr. Ahmad Rizal Ganiem, Sp.S(K), Ph.D
 Medicine Linezolid Approved 28-05-2019
163 Safety , Tolerability Immunogenicity And Protective Efficacy Against Naturally Transmitted Malaria In Eastern Indonesia Of Two Plasmodium Falciparum Sporozoite Vaccines Sanaria Pfspz Vaccine And Sanaria Pfspz-cvac : A Randomized Double Blind Placebo Controlled Phase 2 Trial In Healthy Indonesian Adults II Global Sanaria Inc USA
 Eijkman Oxford Clinical Research Unit (EOCRU)
Fakultas Kedokteran Universitas Indonesia
a. Markas Batalyon Infanteri 132 Bangkinang
dr. Erni Juwita, SpPD
 Vaccine Sanaria PfSPZ Vaccine Approved 10-05-2019 Completed
164 Efektivitas Keamanan Dan Efek Samping Injeksi Cyclonate Yang Diproduksi Oleh Pt. Catur Dakwah Crane Farmasi, Indonesia Dibandingkan Dengan Injeksi Cyclofem Yang Diproduksi Oleh Pt Tunggal Idaman Abadi III Local PT. CaturDakwah Crane Farmasi
 PT. Pharma Metric Labs
1.RSUP Dr. Kariadi
2.RSUP Dr. Sardjito
3.Bali Royal Hospital
4.RSIA Husada Bunda
 Dr.dr. Syarief Thaufik, Sp.OG(K)

1. dr. Nurvita Nindita, SpOG
2. dr. Shofwal Widad, SpOG(K)
3. dr. Ida Bagus Putra Adnyana, SpOG(K.Fer)
4. Dr. dr. I Wayan Arsana Wiyasa, SpOG(K)
 Medicine Cyclofem /Cyclonate Approved 22-04-2019
165 Dia - Ramadan Observational Study Program Assessing Effectiveness And Tolerability Of Gliclazide Mr 60 Mg In Patients With Type 2 Diabetes Fasting During Ramadan IV Local Servier Global Medical Affairs
 PT. Servier Indonesia
1.RSUD Dr. Saiful Anwar
2.RSUD Dr. Soetomo
3.RSUP Fatmawati
4.RS Mitra Keluarga Kelapa Gading
5.RS Gading Pluit
6.RSUP Dr. Hasan Sadikin
7.RSUP Dr. Sardjito
8.RS Panti Rapih
9.RSUD Dr. Moewardi
10.RSUD Dr. Zainoel Abidin
1. Prof. Dr. dr. Achmad Rudijanto, SpPD-KEMD
2. Prof. Dr. Agung Pranoto, dr., SpPD-KEMD, FINASIM
3. dr. Ida Ayu Khsanti
4. dr. Fatimah Eliana
5. dr. Benny Santosa
6. dr. Nanny Natalia
7. dr. Bowo Pramono
8. dr. FX Suharnadi
9. dr. Eva Nia M.
10. dr. Hendra Zufrie
 Medicine Gliclazide Approved 04-04-2019
166 The Evaluation Of A Standard Treatment Regimen Of Antituberculosis Drugs For Patients With Mdr-tb (stage 2) III Global The International Union Againts Tuberculosis and Lung Disease (Vital Strategies)
 PT. IQVIA
RSUP Persahabatan
dr. Erlina Burhan,Sp.P (K)
 Biological Product Standard Treatment Antituberculosis (MDR-TB) Approved 19-03-2019
167 Safety And Efficacy Of Early Start Deferiprone Tretament In Infants And Young Children Newly Diagnosed With Transfusion - Dependent Beta Thalassemia (start) III Global ApoPharma Inc, Canada
 PT. IQVIA
1.RSUPN Dr. Cipto Mangunkusumo
2.RSUP Dr. Hasan Sadikin
1. Dr.dr. Pustika Amalia Wahidiyat SpA(K)
2. Dr. dr. Lelalni Reniarti SpA(K), M.Kes
 Medicine Deferiprone Approved 04-01-2019
Last Updated on : 05-06-2026 11:22

GCP Inspection Data

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No Clinical Trial Protocol Title Sponsor CRO Clinical Trial Center Principal Investigator Investigational Product Type Investigational Product Name Start Date of Implementation End Date of Implementation CAPA Status Regulatory Actions
1 Phase I Randomized Double-blind Study On The Safety And Immunogenicity Of The Dtwp–hepatitis B–hib–sipv (bio Farma) Vaccine Administered After Birth-dose Priming With The Recombinant Hepatitis B (bio Farma) Vaccine In Indonesian Infants PT Bio Farma
Departemen Ilmu Kesehatan Anak, FK Universitas Padjadjaran Bandung
a. RSUD Bandung Kiwari
Dr. Eddy Fadlyana, dr.,Sp.A,Subsp.TKPSK, M.Kes
 Vaccine Hexavalent vaccine 31-03-2026 01-04-2026 Closed NA
2 Phase 3, Double-blind, Placebo-controlled Study Of Recce®327 Topical Gel For The Treatment Of Diabetic Foot Ulcer Infections Recce Pharmaceuticals Ltd.
 PT Increase Laboratorium Indonesia
Siloam Hospitals Lippo Village (SHLV)
Dr. dr. Theo Audi Yanto, SpPD, FINASIM, AIFO-K
 Medicine RECCE327 Topical Gel 10-03-2026 11-03-2026 In Process of Fulfillment NA
3 A Phase 3, Randomized, Double-blind, Placebo-controlled Study To Evaluate The Safety, Immunogenicity, And Efficacy Of V181 Dengue Vaccine In Healthy Participants 2 To 17 Years Of Age PT. Merck Sharp and Dohme Indonesia
Departemen Ilmu Kesehatan Anak, FK Universitas Indonesia - RSCM
a. Puskesmas Pasar Minggu
b. Puskesmas Kelapa Gading
dr. Mulya Rahma Karyanti, Sp.A (K)., M.Sc.,PhD
 Vaccine V181 Dengue Vaccine 02-03-2026 03-03-2026 In Process of Fulfillment NA
4 Immunogenicity And Safety Following In-house Recombinant Hepatitis B (bio Farma) Vaccine Compared To Hepatitis B (bio Farma)® Vaccine In Indonesian Population PT BIO FARMA
Departemen Ilmu Kesehatan Anak Fakultas Kedokteran Universitas Udayana, RSUP Prof. Dr. I.G.N.G Ngoerah, Bali
a. Puskesmas 1 Denpasar Selatan
Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)
 Vaccine Hepatitis B Vaccine 01-12-2025 03-12-2025 In Process of Fulfillment NA
5 A Phase I Randomized, Double-blind, Placebo- Controlled And Dose-escalation Study To Evaluate The Safety And Immunogenicity Of A Viral Vector-based Tuberculosis (tb) Vaccine Ad5-105k Against Tb Disease In Adults Aged 18 To 49 Years PT. Etana Biotechnologies Indonesia
 PT. Increase Laboratorium Indonesia
Rumah Sakit Islam Jakarta (RSIJ) Cempaka Putih
 DR. dr. Erlina Burhan, Sp.P(K), MSc

dr. Fanny Fachrucha, Sp.P(K)
 Vaccine Ad5-105K 06-10-2025 07-10-2025 Closed NA
6 A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial To Assess The Prophylactic Efficacy, Safety, And Immunogenicity Of The Investigational M72/as01e-4 Mycobacterium Tuberculosis (mtb) Vaccine When Administered Intramuscularly On A 0,1-month Schedule To Adolescents And Adults Gates Medical Research Institute
 PT IQVIA RDS Indonesia
RS Universitas Indonesia
 DR. dr. Erlina Burhan, Sp.P(K), MSc

dr. Rania Imaniar, Sp.P
 Vaccine M72/AS01E-4 11-08-2025 12-08-2025 Closed NA
7 A Phase I/ii Randomized, Double-blind, Positive-controlled Dose-exploration Study To Evaluate The Safety And Immunogenicity Of A Virus-like Particle (vlp) Based Vaccine Against Poliomyelitis (vlp-polio) In Infants From 6 Weeks Of Age And Toddlers 12-18 Months Of Age CanSino Biologics Inc.
 Tigermed Consulting Indonesia
RSUP Prof. Dr. I.G.N.G Ngoerah, Denpasar
 dr. Nina Dwi Putri, Sp.A SubsIPT (K), MSc

Dr. dr. I Made Gede Dwi Lingga Utama, Sp.A (K)
 Vaccine VLP-Polio 07-08-2025 08-08-2025 Closed NA
8 A Randomized, Double-blind, Multicenter, Phase Ii/iii Clinical Study Of Serplulimab In Combination With Bevacizumab And Chemotherapy (xelox) Versus Placebo In Combination With Bevacizumab And Chemotherapy (xelox) In First-line Treatment Of Patients With Metastatic Colorectal Cancer (mcrc) Shanghai Henlius Biotech, Inc.
 PT. Pharma Metric Labs
RSU Sentra Medika Cibinong
Dr. dr. Andika Rachman Sp.PD-KHOM
 Medicine Serplulimab 21-07-2025 22-07-2025 In Process of Fulfillment NA
9 A Phase Iii, Randomized, Investigator-blinded, Active Controlled Study Of Efficacy And Safety Of Efepoetin Alfa For Treatment Of Anemia In Patients With Chronic Kidney Disease On Dialysis Genexine, Inc.
 PT. Pharma Metric Labs
Rumah Sakit Islam Jakarta, Cempaka Putih
 dr. Pringgodigdo Nugroho, Sp.PD-KGH

dr. Kuspuji Dwitanto Rahardjo, Sp.PD-KGH
 Biological Product Efepoetin Alfa 17-07-2025 18-07-2025 Closed NA
10 A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial To Assess The Prophylactic Efficacy, Safety, And Immunogenicity Of The Investigational M72/as01e-4 Mycobacterium Tuberculosis (mtb) Vaccine When Administered Intramuscularly On A 0,1-month Schedule To Adolescents And Adults Gates Medical Research Institute
 PT IQVIA RDS Indonesia
RSUP Persahabatan
 Dr. dr. Erlina Burhan, Sp.P(K), MSc

Dr. dr. Fathiyah Isbaniah, M.Pd.Ked., Sp.P(K)
 Vaccine M72/AS01E-4 07-05-2025 08-05-2025 Closed NA
11 A Multi-center, Randomized, Blinded, Active-controlled, Phase 3 Clinical Study To Evaluate The Immunogenicity And Safety Of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered With Hexavalent Vaccine At 2, 4 And 12-15 Months Of Age To Health Infants In Indonesia Minhai Biotechnology Co., Ltd
 PT. Prodia DiaCRO Laboratories
Program Studi Magister Ilmu Kesehatan Masyarakat Fakultas Kedokteran Universitas Udayana
Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)
 Vaccine PCV13-TT 06-05-2025 08-05-2025 Closed NA
12 A Phase I/ii Randomized, Double-blind, Positive-controlled Dose-exploration Study To Evaluate The Safety And Immunogenicity Of A Virus-like Particle (vlp) Based Vaccine Against Poliomyelitis (vlp-polio) In Infants From 6 Weeks Of Age And Toddlers 12-18 Months Of Age CanSino Biologics Inc.
 Tigermed Consulting, Co., Ltd. Indonesia
RSUPN Dr. Cipto Mangunkusumo
dr. Nina Dwi Putri, Sp.A SubsIPT (K), MSc
 Vaccine VLP-Polio 29-04-2025 30-04-2025 Closed NA
13 A Multi-center, Randomized, Blinded, Active-controlled, Phase 3 Clinical Study To Evaluate The Immunogenicity And Safety Of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered With Hexavalent Vaccine At 2, 4 And 12-15 Months Of Age To Health Infants In Indonesia Minhai Biotechnology Co., Ltd
 PT Prodia Diacro Laboratories
Departemen Ilmu Kesehatan Anak FK Universitas Padjadjaran/ RSUP dr. Hasan Sadikin Bandung
a. Puskesmas Ibrahim Adjie
b. Puskesmas Garuda
Dr. dr. Eddy Fadlyana, Sp.A(K)., MKes.
 Vaccine Pneuminvac 21-04-2025 22-04-2025 Closed NA
14 A Randomized, Double-blind, Multicenter, Phase Ii/iii Clinical Study Of Serplulimab In Combination With Bevacizumab And Chemotherapy (xelox) Versus Placebo In Combination With Bevacizumab And Chemotherapy (xelox) In First-line Treatment Of Patients With Metastatic Colorectal Cancer (mcrc) 1.Shanghai Henlius Biotech, Inc.
2.PT Kalbe Genexine Biologics
 PT. Pharma Metric Labs
RS MRCCC Siloam Semanggi
 Prof. Dr. dr. Aru Wisaksono Sudoyo, SpPD-KHOM, FACP

dr. Ralph Girson Gunarsa Sp.PD-KHOM
 Medicine Serplulimab 19-03-2025 20-03-2025 Closed NA
15 A Phase Iii, Randomized, Investigator-blinded, Active Controlled Study Of Efficacy And Safety Of Efepoetin Alfa For Treatment Of Anemia In Patients With Chronic Kidney Disease On Dialysis Genexine, Inc.
 PT. Pharma Metric Labs
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
dr. Jonny, Sp.PD-KGH, M.Kes., MM
 Biological Product Efepoetin Alfa 17-03-2025 18-03-2025 Closed NA
16 A Phase I/ii Randomized, Double-blind, Positive-controlled Dose-exploration Study To Evaluate The Safety And Immunogenicity Of A Virus-like Particle (vlp) Based Vaccine Against Poliomyelitis (vlp-polio) In Infants From 6 Weeks Of Age And Toddlers 12-18 Months Of Age CanSino Biologics Inc.
 Tigermed Consulting Indonesia
RS Universitas Airlangga
Prof. Dr. dr. Nasronudin, Sp.PD., KPTI-FINASIM
 Vaccine VLP-Polio 26-02-2025 27-02-2025 Closed NA
17 A Phase I/ii Randomized, Double-blind, Positive-controlled Dose-exploration Study To Evaluate The Safety And Immunogenicity Of A Virus-like Particle (vlp) Based Vaccine Against Poliomyelitis (vlp-polio) In Infants From 6 Weeks Of Age And Toddlers 12-18 Months Of Age CanSino Biologics Inc.
 Tigermed Consulting Indonesia
RSUP Prof. Dr. I.G.N.G Ngoerah, Denpasar
Dr. dr. I Made Gede Dwi Lingga Utama, Sp.A (K)
 Vaccine VLP-Polio 23-01-2025 24-01-2025 Closed NA
18 A Phase I/ii Randomized, Double-blind, Positive-controlled Dose-exploration Study To Evaluate The Safety And Immunogenicity Of A Virus-like Particle (vlp) Based Vaccine Against Poliomyelitis (vlp-polio) In Infants From 6 Weeks Of Age And Toddlers 12-18 Months Of Age PT Etana Biotechnologies Indonesia
 Tigermed Consulting, Co., Ltd. Indonesia
RSUPN Dr. Cipto Mangunkusumo
 dr. Nina Dwi Putri, SpA.SubsIPT(K), MSc

dr. Nina Dwi Putri, SpA.SubsIPT(K), MSc
 Vaccine VLP-Polio 09-12-2024 10-12-2024 Closed NA
19 A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial To Assess The Prophylactic Efficacy, Safety, And Immunogenicity Of The Investigational M72/as01e-4 Mycobacterium Tuberculosis (mtb) Vaccine When Administered Intramuscularly On A 0,1-month Schedule To Adolescents And Adults Bill & Melinda Gates Medical Research Institute
 PT IQVIA RDS Indonesia
Rumah Sakit Islam Jakarta Cempaka Putih
 Prof. Dr. dr. Erlina Burhan, Sp.P(K), MSc

dr. Cut Yulia Indah Sari, Sp.P
 Vaccine M72/AS01E-4 02-12-2024 03-12-2024 Closed NA
20 A Phase I/ii Randomized, Double-blind, Positive-controlled Dose-exploration Study To Evaluate The Safety And Immunogenicity Of A Virus-like Particle (vlp) Based Vaccine Against Poliomyelitis (vlp-polio) In Infants From 6 Weeks Of Age And Toddlers 12-18 Months Of Age PT Etana Biotechnologies Indonesia
 Tigermed Consulting, Co., Ltd. Indonesia
RS Universitas Airlangga
 dr. Nina Dwi Putri, SpA.SubsIPT(K), MSc

Prof. Dr. Nasronudin dr., Sp.PD., KPTI.FINASIM
 Vaccine VLP-Polio 02-12-2024 03-12-2024 Closed NA
21 A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial To Assess The Prophylactic Efficacy, Safety, And Immunogenicity Of The Investigational M72/as01e-4 Mycobacterium Tuberculosis (mtb) Vaccine When Administered Intramuscularly On A 0,1-month Schedule To Adolescents And Adults Bill & Melinda Gates Medical Research Institute
 PT IQVIA RDS Indonesia
Fakultas Kedokteran Universitas Indonesia
a. Puskesmas Kramat Jati
b. Puskesmas Kemayoran
 Prof. Dr. dr. Erlina Burhan, Sp.P(K), MSc

Prof. Dr. dr. Sri Rezeki Hadinegoro, Sp.A(K)
 Vaccine M72/AS01E-4 28-11-2024 29-11-2024 Closed NA
22 A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial To Assess The Prophylactic Efficacy, Safety, And Immunogenicity Of The Investigational M72/as01e-4 Mycobacterium Tuberculosis (mtb) Vaccine When Administered Intramuscularly On A 0,1-month Schedule To Adolescents And Adults Bill & Melinda Gates Medical Research Institute
 PT IQVIA RDS Indonesia
Research Center for Care and Control of Infectious Disease (RC3ID) Universitas Padjadjaran
 Prof. Dr. dr. Erlina Burhan, Sp.P(K), MSc

Prof. dr. Rovina Ruslami, Sp.PD, PhD
 Vaccine M72/AS01E-4 25-11-2024 26-11-2024 Closed NA
23 A Randomized, Observer Blinded, Active Controlled Phase 3 Study To Evaluate Theimmunogenicity And Safety Of Candidate Recombinant Nonavalent (types6/11/16/18/31/33/45/52/58) Human Papillomavirus (hpv) Vaccine (escherichia Coli) Administered Intramuscularly In Healthy Female Participants Aged 18 To 45 Years” Beijing Health Guard Biotechnology, Inc
 PT Equilab International
RSUP Dr. M.Djamil , Padang
dr. Asrawati, M. Biomed, Sp.A(K)
 Vaccine HPV 17-10-2024 18-10-2024 Closed NA
24 A Randomized Trial Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1hp) To Weekly Rifapentine & Isoniazid For 3 Months (3hp) In Persons Living With Hiv And In Hiv Negative Household Contacts Of Recently Diagnosed Tuberculosis Patients, The “one To Three” Trial Yayasan KNCV Indonesia
RSUP Persahabatan
Dr. dr. Erlina Burhan M.Sc, Sp.P(K)
 Medicine Rifapentine & Isoniazid 23-07-2024 24-07-2024 Closed NA
25 A Phase 3, Randomized, Blinded, Active-controlled Study To Evaluate The Immunogenicity And Safety Of Walvax’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (pcv13-tt) As Compared To Pfizer’s 13-valent Pneumococcal Conjugate Vaccine (pcv13) Co-ad Yuxi Walvax Biotechnologies
 PT Prodia DiaCRO Laboratories
Fakultas Kedokteran Universitas Udayana
a. Puskesmas I Denpasar Selatan
Dr.dr. I Gusti Ayu Trisna Windiani, SpA(K)
 Vaccine PCV13-TT 27-06-2024 28-06-2024 Closed Warning
26 A Multicenter, Randomized, Double-blinded, Positivec Ontrolled Phase Ⅲ Clinical Trial To Evaluate Lot-to-lot Consistency, Immunogenicity And Safety Of Group Acyw135 Meningococcal Conjugate Vaccine (crm197) In Adults Aged 18 To 55 Years CanSino Biologics Inc..
 Tigermed Indonesia
1.RS Universitas Airlangga
2.RS Husada Utama
 Dr. dr. Erni Juwita Nelwan, Ph.D, Sp.PD-KPTI, FACP, FINASIM

1. Prof. Dr. dr. Nasronudin, Sp.PD-KPTI, FINASIM
2. dr. Isti Suharjanti, Sp.S(K)
 Vaccine MCV (CRM197) 07-05-2024 08-05-2024 Closed NA
27 A Phase 3, Randomized, Blinded, Active-controlled Study To Evaluate The Immunogenicity And Safety Of Walvax’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (pcv13-tt) As Compared To Pfizer’s 13-valent Pneumococcal Conjugate Vaccine (pcv13) Co-administered With Epi Vaccines At 2, 4, And 12-15 Months Of Age, To Healthy Infants In Indonesia Yuxi Walvax Biotechnologies
 PT Prodia DiaCRO Laboratories
RSUPN Dr. Cipto Mangunkusumo
a. Puskemas Jatinegara
Dr. dr. Nastiti Kaswandari. SpA(K)
 Vaccine PCV13-TT 29-04-2024 30-04-2024 Closed NA
28 A Randomized, Observer Blinded, Active Controlled Phase 3 Study To Evaluate Theimmunogenicity And Safety Of Candidate Recombinant Nonavalent (types6/11/16/18/31/33/45/52/58) Human Papillomavirus (hpv) Vaccine (escherichia Coli) Administered Intramuscularly In Healthy Female Participants Aged 18 To 45 Years Beijing Health Guard Biotechnology, Inc
 PT Equilab International
RSU Universitas Muhammadiyah Malang
Prof. Dr. dr. Djoni Djunaedi, Sp.PD, KPTI
 Vaccine Vaksin HPV 07-03-2024 08-03-2024 Closed NA
29 Effectivenesss & Safety Of Ovine Enoxaparin Sodium To Originator Enoxaparin In Non-st-segment Elevation Acute Coronary Syndrome (nsteacs) Patients: A Multicenter, Non-randomized, Open-label, Non-inferiority Trial PT. Bio Farma
 Clinical Epidemiology and Biostatistics Unit (CEBU) FKKMK Universitas Gadjah Mada
RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta
Dr. dr. Dafsah Arifa Juzar, Sp.JP(K)
 Medicine Enoxaparin 25-01-2024 26-01-2024 Closed NA
30 Immunobridging Study: Immunogenicity And Safety Of Vaksin Merah Putih – Ua Sars-cov-2 (vero Cell Inactivated) Vaccine As Heterologus Booster In Adolescent Subjects Indonesia 1.UNAIR
2.Kemenkes RI
3.PT Biotis
RSUD Dr. Soetomo
Dr. Dominicus Husada, dr., SpA(K)
 Vaccine Vaksin Inavac 07-12-2023 08-12-2023 Closed NA
31 The Effect Of Incremental Continuous Ambulatory Peritoneal Dialysis On The Preservation Of Residual Kidney Function And Clinical Outcomes: A Randomized Controlled Trial Prof. dr. Aida Lydia, PhD, Sp.PD-KGH
RSUP Dr. Cipto Mangunkusumo
Prof. dr. Aida Lydia, PhD, Sp.PD-KGH
 Medicine Icodextrin 30-11-2023 01-12-2023 Closed NA
32 Immunogenicity & Safety Of Indovac As A Homologous Booster Dose Against Covid-19 In Adults Aged 18 Years And Above In Indonesia PT. Bio Farma
 PT. Equilab International
Fakultas Kedokteran Universitas Diponegoro
a. Puskesmas Mranggen 1, Demak
b. Puskesmas Pringapus, Ungaran
dr. Yetty Movieta Nancy, Sp.A (K)
 Vaccine Vaksin Indovac 23-11-2023 24-11-2023 Closed NA
33 A Parallel Group Treatment, Phase 2/3, Double-blind, Randomized, Placebo-controlled, 3-arm Study To Evaluate The Safety, Tolerability, And Efficacy Of Ad17002 (lth[αk]) Intranasal Spray In Male And Female Participants Aged 18 To 65 Years With Mild To Moderate Covid‑19 A Joint Development By Universitas Gadjah Mada And Advagene Biopharma Advagene Biopharma Co., Ltd. Taiwan
 PT. Equilab International
Rumah Sakit Penyakit Infeksi (RSPI) Prof. Dr. Sulianti Saroso
dr. Adria Rusli, Sp.P
 Medicine AD17002 18-09-2023 19-09-2023 Closed NA
34 High Dose Oral Rifampicin To Improve Survival From Adult Tuberculous Meningitis: A Double-blinded Randomised Controlled Phase Iii Trial (harvest) Infectious Disease Institute Limited, Uganda
RSUP Dr. Hasan Sadikin Bandung
Prof. Rovina Ruslami, dr., Sp.PD, PhD
 Medicine Rifampicin 27-07-2023 28-07-2023 Closed NA
35 An Open Label, Phase Iii Clinical Trial (immunobridging Study) Of Inavac (vaksin Merah Putih – Ua-sars Cov-2 (vero Cell Inactivated)) In Healthy Population Aged 12 To 17 Years Old 1.UNAIR
2.Kemenkes RI
3.PT. Biotis
RSUD. Dr. Soetomo Surabaya
Dr. Dominicus Husada, dr., SpA(K)
 Vaccine Vaksin Inavac 26-06-2023 27-06-2023 Closed NA
36 Immunogenicity And Safety Of Indovac As A Heterologous Booster Dose Against Covid-19 In Children 12-17 Years Of Age PT Bio Farma
 PT Equilab International
Departemen Ilmu Kesehatan Anak, FK Universitas Padjadjaran
a. Puskesmas Garuda
Dr. dr. Eddy Fadlyana, Sp.A(K), M Kes
 Vaccine Vaksin Indovac 29-05-2023 30-05-2023 Closed NA
37 A Randomized, Double-blind, Placebo-controlled Clinical Study To Evaluate The Efficacy, Safety, And Immunogenicity Of Sars-cov-2 Variant (ba.4/5) Mrna Vaccine (abo1020) In Healthy Subjects Aged 18 Years And Older Who Have Completed The Full Vaccination 1.Suzhou Abogen Biosciences Co., Ltd
2.PT Etana Biotechnologies Indonesia
 PT. Tigermed Consulting Indonesia
RS Yarsi
dr. Efriadi Ismail, Sp.P
Vaccine Vaksin mRNA 10-05-2023 12-05-2023 Closed NA
38 A Randomized, Double-blind, Placebo-controlled Clinical Study To Evaluate The Efficacy, Safety, And Immunogenicity Of Sars-cov-2 Variant (ba.4/5) Mrna Vaccine (abo1020) In Healthy Subjects Aged 18 Years And Older Who Have Completed The Full Vaccination 1.Suzhou Abogen Biosciences Co., Ltd
2.PT Etana Biotechnologies Indonesia
 PT. Tigermed Consulting Indonesia
RS Universitas Indonesia
dr. Rania Imaniar, Sp.P
 Vaccine Vaksin mRNA 20-03-2023 21-03-2023 Closed NA
39 Bevacizumab Compared To Avastinâ In Combination With Capecitabine Plus Oxaliplatin (capeox) As First-line Therapy In Metastatic Colorectal Cancer: A Preliminary Open-label Study PT. Etana Biotechnologies
 Clinical Research Supporting Unit (CRSU) FK Universitas Indonesia
RS Kanker Dharmais
dr. Ronald Alexander Hukom, Sp.PD, KHOM, MHSC, FINASIM
 Medicine Bevacizumab 20-02-2023 21-02-2023 Closed NA
40 Open Label Randomised Controlled Trial Of Efepoetin Alfa For Treatment Of Anemia Associated With Chronic Kidney Disease Patients Not On Dialysis (nd-ckd). A Non-inferiority Trial Compared To Methoxy Polyethylene Glycol-epoetin Beta (mircera) PT. Kalbe Genexine Biologics
 PT Pharma Metric Labs
RS Islam Jakarta, Cempaka Putih
dr. Kuspudji Dwitanto R, SpPD-KGH
 Biological Product Efepoetin Alfa 31-01-2023 01-02-2023 Closed Warning
41 Efficacy, Safety And Immunogenicity Of Rotavirus Rv3 Vaccine (bio Farma) In Neonates, Lot To Lot Consistency And Antigen Interference With Co-administered Epi Vaccines (phase Iii) PT. Bio Farma
 IQVIA RDS Indonesia
Pediatric Research Center Universitas Sebelas Maret (PRC UNS)
dr. Hary Wahyu N, M.Kes., Sp.A(K)
 Vaccine Vaksin Rotavirus 25-01-2023 26-01-2023 Closed NA
42 A Phase Iii, Observer-blind, Randomized, Controlled Study Of The Safety And Immunogenicity Of Sars-cov2 Protein Subunit Recombinant Vaccine In Healthy Children Aged 12-17 Years In Indonesia PT. Bio Farma
 PT. Equilab International
Pediatric Research Office (PKKA-PRO) Universitas Gadjah Mada
a. RS Universitas Mataram, Nusa Tenggara Barat
dr. Cahya Dewi Satria, M.Kes., Sp.A(K).
a. dr. Putu Aditya Wiguna M.Sc Sp.A
 Vaccine Vaksin IndoVac 13-12-2022 14-12-2022 Closed NA
43 A Phase Iii, Observer-blind, Randomized, Controlled Study Of The Safety And Immunogenicity Of Sars-cov-2 Protein Subunit Recombinant Vaccine In Healthy Children Aged 12-17 Years In Indonesia PT. Bio Farma
 PT. Equilab International
Pediatric Research Office (PKKA-PRO) Universitas Gadjah Mada
a. RSUD Dr. H. Abdoel Moeloek, Lampung
dr. Cahya Dewi Satria, M.Kes., Sp.A(K).
a. dr. Prambudi Rukmono, Sp.A(K)
 Vaccine Vaksin IndoVac 01-12-2022 02-12-2022 Closed NA
44 A Phase 2, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single Administration Study To Evaluate The Safety And Efficacy Of Gx-i7 In Elderly Patients With Severe Acute Respiratory Syndrome Coronavirus (sars-cov-2) Infection 1.Genexine, Inc. Korea
2.PT Kalbe Genexine Biologics
 PT. Pharma Metric Labs
1.RS Mitra Keluarga Bintaro
2.RS Ukrida
1. Dr. Okki Ramadian, SpPD
2. dr. Chrispian Oktafbipian Mamudi, Sp.PD-KP
 Biological Product GX-I7 23-11-2022 24-11-2022 Closed
45 A Global, Multi-center, Randomized, Double-blind, Placebo-controlled, Phase Lll Clinical Study To Evaluate The Protective Efficacy, Safety And Lmmunogenicity Of Sars-cov-2 Messenger Ribonucleic Acid (mrna) Vaccine In Population Ased 18 Years And Older 1.Suzhou Abogen Biosciences Co., Ltd. China
2.PT. Etana Biotechnologies Indonesia
 PT. Tigermed Consulting Indonesia
Rumah Sakit Umum Pusat Persahabatan, Jakarta
a. Puskesmas Mauk, Kabupaten Tangerang
Dr. dr. Erlina Burhan, MSc, SpP(K)
 Vaccine Vaksin mRNA 16-11-2022 18-11-2022 Closed NA
46 Observer-blind, Randomized, Controlled Study Of Immunogenicity And Safety Of Sars-cov-2 Protein Subunit Recombinant Vaccine (bio Farma) As A Booster Dose Against Covid-19 In Adults 18 Years Of Age And Older PT. Bio Farma
 PT Equilab International
RSUP Prof. I.G.N.G Ngoerah-FK Universitas Udayana
Dr.dr.I Gusti Ayu Trisna Windiani, Sp.A(K)
 Vaccine Indovac 27-10-2022 28-10-2022 Closed NA
47 A Randomized, Double-blind, And Placebo-controlled Phase 1 Clinical Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Sars-cov-2 Variant Mrna Vaccines (abo1009-dp And Abo-cov.617.2) In Indonesian Subjects Aged 18 Years And Older Who Have Not Received Sars-cov-2 Vaccines 1.Suzhou Abogen Biosciences Co., Ltd.
2.PT Etana Biotechnologies Indonesia
 PT. Tigermed Consulting Indonesia
1.RSUP Persahabatan
2.RSUPN Dr. Cipto Mangunkusumo
 Dr. dr. Erlina Burhan, MSc, Sp.P(K)

1. Dr. dr. Fathiyah Isbaniah, Sp. P(K), MPd, Ked
2. Dr. dr. Sukamto Koesnoe, Sp.PD-KAI
 Vaccine SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO-CoV.617.2) 19-10-2022 21-10-2022 Closed NA
48 Observer-blind, Randomized, Controlled Study Of Immunogenicity And Safety Of Sars-cov-2 Protein Subunit Recombinant Vaccine (bio Farma) As A Booster Dose Against Covid-19 In Adults 18 Years Of Age And Older PT. Bio Farma
 PT. Equilab International
Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Padjadjaran
Prof. Dr. dr. Kusnandi Rusmil, SpA(K), MM
 Vaccine Vaksin IndoVac 13-10-2022 14-10-2022 Closed NA
49 2r2: Higher Dose Rifampin For 2 Months Vs Standard Dose Rifampin For Latent Tb:a 3-arm Randomized Trial Mcgill International TB Centre, Canada
FK Universitas Padjadjaran Bandung
Prof. Rovina Ruslami, dr., Sp.PD, PhD
 Medicine Rifampicin 29-09-2022 30-09-2022 Closed NA
50 A Multicenter, Randomized, Double Blind, Controlled, Phase Iii Clinical Trial (immunobridging Study) Of Vaksin Merah Putih – Ua Sars-cov-2 (vero Cell Inactivated) In Healthy Population Aged 18 Years And Above 1.BKPK Kemenkes RI
2.PT Biotis
3.Universitas Airlangga
RSUD Dr. Soetomo, Surabaya
a. RS Paru Jember
b. RSUD. Dr. Soebandi, Jember
Dr. Dominicus Husada, dr., Sp.A(K)
a. dr. Sigit Kusuma Jati, MM
b. dr. Retna Dwi Puspitarini, Sp.P
 Vaccine Inavac 22-09-2022 23-09-2022 Closed Warning
51 Safety, Tolerability, Immunogenicity And Protective Efficacy Against Naturally-transmitted Malaria In Eastern Indonesia Of Two Plasmodium Falciparum Sporozoite Vaccines, Sanaria® Pfspz Vaccine And Sanaria® Pfspz-cvac: A Randomized, Double-blind, Placebo-controlled Phase 2 Trial In Healthy Indonesian Adults Sanaria Inc, USA
 Eijkman Oxford Clinical Research Unit (EOCRU)
Divisi Penyakit Infeksi dan Tropis, Departemen Penyakit Dalam, Fakultas Kedokteran Universitas Indonesia Jakarta
a. Markas Batalyon Infanteri 132 Bangkinang, Riau
DR. Dr. Erni J. Nelwan, SpPD, KPTI, PhD
 Vaccine Sanaria® PfSPZ Vaccine,Sanaria® PfSPZ-CVac 01-09-2022 02-09-2022 Closed NA
52 Immunogenicity & Safety Of Sars-cov-2 Protein Subunit Recombinant Vaccine (bio Farma) Adjuvanted With Alum+cpg 1018 Compared To Registered Covid-19 Vaccine (covovax – Protein Subunit Vaccine) In Healthy Populations Aged 18 Years And Above In Indonesia (phase Iii) PT. Bio Farma
 PT. Equilab International
Fakultas Kedokteran Universitas Andalas Padang
a. RS Universitas Andalas
b. RSUD Padang Pariaman
dr. Asrawati, M.Biomed, SpA(K)
 Vaccine Vaksin IndoVac 18-07-2022 19-07-2022 Closed NA
53 A Phase Iiib/iv Randomized Open Label Trial To Compare Dolutegravir With Pharmaco-enhanced Darunavir Versus Dolutegravir With Predetermined Nucleosides Versus Recommended Standard Of Care Antiretroviral Regimens In Patients With Hiv-1 Infection Who Have Failed Recommended First Line Therapy University of New South Wales, Australia
 INA RESPOND (Badan Kebijakan Pengembangan Kesehatan)
RSUPN Dr. Cipto Mangunkusumo
Dr. dr. Evy Yunihastuti, Sp.PD-KAl FINASIM
 Medicine Dolutegravir,Darunavir 14-07-2022 15-07-2022 Closed NA
54 Studi Klinis Fase Iii, Acak, Tersamar Ganda, Terkontrol Plasebo Untuk Mengevaluasi Efikasi Dan Keamanan Proxalutamide (gt0918) Pada Pasien Rawat Inap Covid-19 PT. Etana Biotechnologies Indonesia
RSUP Persahabatan
dr. Triya Damayanti,SpP(K), PhD
 Medicine Proxalutamide 29-06-2022 30-06-2022 Closed NA
55 Immunogenicity And Safety Study Of Half Dose Of Moderna Covid-19 Vaccine Booster Heterologous In Adult Subjects In Indonesia Badan Kebijakan Pembangunan Kesehatan, Kementerian Kesehatan Republik Indonesia
Fakultas Kedokteran Universitas Indonesia - RSCM
a. Puskesmas Cempaka Putih
dr. Nina Dwi Putri, Sp.A(K)
 Vaccine Vaksin Moderna 18-05-2022 19-05-2022 Closed NA
56 Safety And Immunogenicity Of Unair Inactivated Covid-19 Vaccine In Healthy Population Aged 18 Years And Above (phase I/ii) 1.BKPK Kemenkes RI
2.PT Biotis
3.Unair
RSUD Dr. Soetomo, Surabaya
Dr. Dominicus Husada, dr., Sp.A(K)
 Vaccine Inavac 24-03-2022 25-03-2022 Closed NA
57 A Phase Ii Non-randomized Open Labelled Clinical Trial To Evaluate The Safety & Immunogenicity Of Sars-cov-2 Vaccine (vero Cell) Inactivated As A Booster Dose PT Kimia Farma
Laboratorium Klinik Kimia Farma Radio Dalam, Jakarta
dr Andi Wiradharma, SpPK
 Vaccine Vaksin SARS-COV-2 (Vero Cell) Sinopharm 14-03-2022 15-03-2022 Closed NA
58 Safety And Immunogenicity Of Unair Inactivated Covid-19 Vaccine In Healthy Population Aged 18 Years And Above (phase I/ii) 1.BKPK
2.UNAIR
3.PT Biotis
RSUD Dr. Soetomo, Surabaya
Dr. Dominicus Husada, dr., Sp.A(K)
 Vaccine Vaksin Inavac 02-02-2022 03-02-2022 Closed NA
59 Global, Multi-center, Randomized, Double-blind, Placebo-controlled, Phase Iii Clinical Study To Evaluate The Protective Efficacy, Safety, And Immunogenicity Of Recombinant Sars-cov-2 Fusion Protein Vaccine (v-01) In Adults Aged 18 Years And Older) Livzon
 PT. Equilab International
Fakultas Kedokteran Universitas Islam Negeri Syarif Hidayatullah
a. KPKM Renijaya, Tangerang
Dr. Hari Hendarto, PhD, SpPD-KEMD, FINASIM
 Vaccine Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) 20-01-2022 26-01-2022 Closed NA
60 Immunogenicity And Safety Study Of Half And Full Dose Of Heterologous And Homologous Covid-19 Vaccine Booster In Adult Subjects In Indonesia (bcov-21) Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan Republik Indonesia (Balitbangkes, Kemenkes RI)
RSUP Dr. Hasan Sadikin Bandung
a. Klinik Kesehatan Unpad
b. Puskesmas Ciumbuleuit
Dr. Djatnika Setiabudi, dr., SpA(K)
 Vaccine Vaksin AstraZeneca, Pfizer, Sinovac 23-12-2021 24-12-2021 Closed NA
61 A Phase I/ii, Placebo-controlled, Randomized, Double-blind, Dose-finding Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Adimrsc-2f Vaccine In Healthy Adults Adimmune Corporation, Taiwan
 PT. IQVIA RDS Indonesia
Rumah Sakit Akademik Universitas Gadjah Mada, Yogyakarta
Supriyati, Dr., S.Sos., M.Kes
 Vaccine Vaksin AdimrSc-2f 13-12-2021 14-12-2021 Closed NA
62 A Global Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Iii Clinical Trial To Evaluate The Efficacy, Safety, And Immunogenicity Of Recombinant Covid-19 Vaccine (sf9 Cells), For The Prevention Of Covid-19 In Adults Aged 18 Years And Older 1.WestVac Biopharma Co., Ltd,
2.West China Hospital of Sichuan University
 PT. Equilab International dan PT. Tigermed Consulting Indonesia
RSUP Persahabatan
a. Puskesmas Ciketingudik, Bekasi
dr. Sita Andarini, Sp.P(K), Ph.D
a. dr. Elisabeth Intan Budi Pratiwi
 Vaccine Vaksin Sf9 08-12-2021 10-12-2021 Closed NA
63 A Global, Multi-center, Randomized, Double-blind, Placebo-controlled, Phase Iii Clinical Study To Evaluate The Protective Efficacy, Safety And Immunogenicity Of Sars-cov-2 Messenger Ribonucleic Acid (mrna) Vaccine In Population Aged 18 Years And Older 1.Yuxi Walvax Biotechnology Co., Ltd.,
2.Walvax Biotechnology Co., Ltd.,
3.Suzhou Abogen Biosciences Co., Ltd.,
4.PT. Etana Biotechnologies Indonesia
 PT. Tigermed Consulting Indonesia
RSUP Persahabatan
a. Puskesmas Kecamatan Pulogadung
b. Puskesmas Kecamatan Kalideres
dr. Erlina Burhan, MSc, Sp.P(K)
a. dr. Titta Gusni Salim
b. dr. Linda Lidya, M. Epid
 Vaccine Vaksin ARCoV 03-12-2021 07-12-2021 Closed NA
64 A Phase I, Observer-blind, Randomized, Controlled Study Of The Safety And Immunogenicity Of Sars-cov-2 Protein Subunit Recombinant Vaccine In Healthy Populations Aged 18 Years And Above In Indonesia 1.Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan Republik Indonesia
2.PT Bio Farma
Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Indonesia
a. Puskesmas Pancoran Mas, Depok
Prof. Dr. dr. Rini Sekartini, SpA (K)
 Vaccine SARS-CoV-2 Protein Subunit Recombinant Vaccine 26-11-2021 27-11-2021 Closed NA
65 Randomised Evaluation Of Covid-19 Therapy (recovery) University of Oxford
 Eijkman-Oxford Clinical Research Unit
RS Metropolitan Medical Center (MMC), Jakarta
dr. Sandhi Prabowo, Sp.An-KIC
 Medicine Colchicine, Dexamethasone, Empaglifozine 08-11-2021 10-11-2021 Closed NA
66 Uji Klinik Acak Tersamar Ganda Untuk Membandingkan Efikasi Pemberian Remdesivir 5 Dan 10 Hari Pada Pasien Covid-19 Rawat Inap Derajat Sedang Dan Berat (covid-remisi) Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan Republik Indonesia (Balitbangkes, Kemenkes RI)
RSUP Persahabatan Jakarta
dr. Fathiyah Isbaniah, Sp.P(K)
 Medicine Remdesivir 11-10-2021 15-10-2021 Closed NA
67 Efficacy And Safety Of Normoxic Allogenic Umbilical Cord Mesenchymal Stem Cells Administered As Adjunctive Treatment To Standard Treatment In Severe Patients With Covid-19 Badan Riset dan Inovasi Nasional (BRIN), Bifarma Adiluhung
 PT Pharma Metric Labs
RSUD Dr. Moewardi, Surakarta
Dr. dr. Arief Nurudhin, Sp.PD, K-R, FINASIM
 Biological Product UCMSC 20-09-2021 24-09-2021 Closed NA
68 Uji Klinik Fase Ii-iii, Acak, Tersamar Ganda Dengan Kontrol Plasebo Untuk Menilai Keamanan Dan Efikasi Pemberian Oral Ivermectin Pada Pasien Covid-19 Derajat Ringan-sedang-berat Badan Penelitian dan Pengembangan Kesehatan, Kemenkes RI
RSUD dr Soedarso, Pontianak
DR.dr.Pinda Hutajulu,SPOG,(K)-FER
 Medicine Ivermectin 13-09-2021 17-09-2021 Closed NA
69 Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan Covid-19 (plasenter) Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan Republik Indonesia
RSAL dr. Ramelan Surabaya
Kol. Laut (K) dr. Frans O.H.P,SpOG(K)
 Biological Product Plasma Konvalesen 12-08-2021 20-08-2021 Closed NA
70 Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan Covid-19 (plasenter) Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan Republik Indonesia
RSD Gunung Jati Cirebon
dr. Agung Hujjatulislam, Sp.An. KIC
 Biological Product Plasma Konvalesen 12-08-2021 20-08-2021 Closed NA
71 A Phase Iii Randomized, Double-blind, Placebo-controlled Clinical Trial In 18 Years Of Age And Above To Determine The Safety And Efficacy Of Zf2001, A Recombinant Novel Coronavirus Vaccine (cho Cell) For Prevention Of Covid-19 Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., China
 PT. Prodia DiaCRO Laboratories
Departemen Ilmu Kesehatan Anak FK UI-RSUPN Dr. Cipto Mangunkusumo
Prof. Dr. dr. Hindra Irawan, Sp.A(K),M.Trop.Paed
 Vaccine Zifivax 17-06-2021 18-06-2021 Closed NA
72 Efficacy And Safety Of Convalescent Plasma Transfusion Administered As Adjunctive Treatment To Standard Treatment In Moderate, Severe, And/or Critically Ill Patients With Covid-19 Kementerian Riset dan Teknologi – Badan Riset dan Inovasi Nasional
RSUP Dr. Sardjito Yogyakarta
Dr. Johan Kurnianda, SpPD-KHOM
 Biological Product Plasma Konvalesen 15-06-2021 16-06-2021 Closed NA
73 A Phase Iii Randomized, Double-blind, Placebo-controlled Clinical Trial In 18 Years Of Age And Above To Determine The Safety And Efficacy Of Zf2001, A Recombinant Novel Coronavirus Vaccine (cho Cell) For Prevention Of Covid-19 Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., China
 PT. Prodia DiaCRO Laboratories
Departemen Ilmu Kesehatan Anak FK UNPAD-RSHS, Bandung
dr. Rodman Tarigan, Sp.A (K), M.Kes
 Vaccine Vaksin Zifivax 25-03-2021 26-03-2021 Closed NA
74 Uji Klinis Adaptif Fase I Sel Dendritik Autolog Yang Sebelumnya Diinkubasi Dengan Spike Protein Severe Acute Respiratory Syndrome Coronavirus-2 (sars-cov-2) Pada Subjek Yang Tidak Terinfeksi Covid-19 Dan Tidak Terdapat Antibodi Anti Sars-cov-2 Balitbangkes, Kemenkes RI
RSUP Dr. Kariadi Semarang
Dr. dr. Muchlis Achsan Udji, SpPD-KPTI, FINASIM
 Biological Product Sel Dendritik Autolog 12-03-2021 13-03-2021 Closed Warning
75 Fase Iii, Acak-terbuka, Uji Klinik Efikasi Dan Keamanan Favipiravir Pada Pasien Covid-19 Di Indonesia Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan RI
1.RSJ Prof.Dr.Soerojo, Magelang
a.
2.RS TTK II dr. Soedjono, Magelang
a.
3.RS Merah Putih, Magelang
a.
Dr. dr. Armedy Ronny Hasugian, M.Biomed

1. dr. Harli Amir Mahmudji, Sp.PD, KEMD
2. dr. Dwi Hartanto, Sp.P, FIRS
3. dr. Ratna Sulistyani, Sp.PD
 Medicine Favipiravir 17-12-2020 18-12-2020 Closed NA
76 Uji Klinik Adaptif Fase I Sel Dendritik Autolog Yang Sebelumnya Diinkubasi Dengan Spike Protein Severe Acute Respiratory Syndrome Coronavirus-2 ( Sars-cov-2) Pada Subjek Yang Tidak Terinfeksi Covid-19 Dan Tidak Terdapat Antibodi Anti Sars-cov-2 PT. AIVITA Biomedika Indonesia
RSUP Dr. Kariadi Semarang
Dr. dr. Muchlis Achsan Udji, SpPD-KPTI, FINASIM
 Biological Product Sel dendritik 14-12-2020 15-12-2020 Closed
77 Penggunaan Sel Punca Mesenkimal Asal Tali Pusat Sebagai Terapi Pasien Dengan Covid-19 Pneumonia Derajat Kritis PT Kimia Farma (Persero)
RSUP Persahabatan
Prof. Dr. dr. Ismail Hadisoebroto Dilogo, Sp.OT(K)
 Biological Product Sel punca mesenkimal 12-10-2020 27-10-2020 Closed
78 Penggunaan Sel Punca Mesenkimal Asal Tali Pusat Sebagai Terapi Pasien Dengan Covid-19 Pneumonia Derajat Kritis PT Kimia Farma (Persero)
RSUPN Dr. Cipto Mangunkusumo-Fakultas Kedokteran Universitas Indonesia
Prof. Dr. dr. Ismail Hadisoebroto Dilogo, Sp.OT(K)
 Biological Product Sel punca mesenkimal 22-09-2020 02-10-2020
79 Penilaian Efikasi Dan Keamanan Injeksi Bdb-001 Untuk Pengobatan Covid-19 Berat Dan Progresif: Suatu Uji Klinik Fase Ii, Multisenter, Berpembanding, Paralel, Acak Dan Terbuka Staidson (Beijing) Biopharmaceutical Co., Ltd
 PT Etana Biotechnologies Indonesia
1.RSUD Pasar Minggu
2.RSUP Persahabatan
1. Dr. dr. Erlina Burhan, MSc, Sp.P(K)
2.
3.
Medicine BDB-001 20-09-2020 25-09-2020 Closed
80 A Phase Iii, Observer-blind, Randomized, Placebo Controlled Study Of The Efficacy, Safety And Immunogenicity Of Sars-cov-2 Inactivated Vaccine In Healthy Adults Aged 18-59 Years In Indonesia PT Bio Farma
Bagian Ilmu Kesehatan Anak RS Hasan Sadikin Bandung
a. Fakultas Kedokteran UNPAD
b. Balai Kesehatan UNPAD
c. Puskesmas Garuda
d. Puskesmas Ciumbuleuit
e. Puskesmas Dago
f. Puskesmas Sukapakir
Prof. Dr. Kusnandi Rusmil, dr.,Sp.A(K).,MM
 Vaccine Vaksin COVID-19 08-09-2020 09-09-2020 Closed NA
81 An International Randomised Trial Of Additional Treatments For Covid-19 In Hospitalised Patients Who Are All Receiving The Local Standard Of Care” (solidarity Trial) World Health Organization (WHO)
1.RSPI Sulianti Saroso
2.RS YARSI, Jakarta
1. Dr. dr. Indra Kusuma,M.Biomed
2.
3.
Medicine 07-09-2020 15-09-2020 Closed
82 Studi Acak,berpembanding,terbuka Untuk Mengetahui Efektivitas Dan Keamanan Favipiravir Sebagai Terapi Tambahan Terhadap Pengobatan Standar Pada Penderita Covid-19 Kementerian BUMN melalui PT. Pertamina Bina Medika IHC
 Indonesia Healthcare Corporation
RSUPN Cipto Mangunkusumo,Jakarta
 Medicine Favipiravir 19-08-2020 25-08-2020
83 Uji Klinik Fase Iii, Multisenter, Acak Terkontrol, Tersamar Ganda Membandingkan Efikasi Dan Keamanan Kombinasi Baru Lopinavir/ritonavir Azytromycin, Lopinavir/ritonavir Doxycycline, Serta Hydroxychloroquine Azytromycin Dengan Obat Standar Pada Pasien Covid-19 Yang Dirawat Di Rumah Sakit Dengan Derajat Ringan, Sedang, Dan Berat Yang Tidak Menggunakan Ventilator Badan Intelijen Negara (BIN)
RS Dustira Bandung
Dr. Purwati, dr., Sp.PD.,FINASIM.
 Medicine Kombinasi Lopinavir/Ritonavir 27-07-2020 28-07-2020 Closed
84 Pharmacodynamic Equivalence Of Ovine Enoxaparin To Porcine Enoxaparin (lovenox®) In Healthy Volunteers PT. Metiska Farma
PT. Pharma Metric Labs, Jakarta
Prof. Arini Setiawati, PhD
Medicine Enoxaparin 10-02-2020 11-02-2020 Closed
85 Safety And Preliminary Of Immunogenicity Following Recombinant Hepatitis B (bio Farma) Vaccine In Adults & Children (phase I) PT Bio Farma
Fakultas Kedokteran Universitas Padjadjaran, RSUP Dr. Hasan Sadikin, Bandung
1. Prof. Dr. Kusnandi Rusmil, dr., Sp.A(K)., MM
2.
Vaccine Vaksin Hepatitis B 10-02-2020 11-02-2020 Closed NA
86 Non-intervational Study On Effectiveness And Safety Of Fixed Dose Combination Of Netupitant And Palonosetron (nepa) In Chemotherapy Induced Nausea And Vomiting (cinv) Patients Receiving Moderately (mec) Or Highly Emetogenic Chemotherapy (hec) Mundipharma Laboratories GmBH
 PT Prodia Diacro Laboratories
1.RS Medistra Jakarta
2.RS Kanker Dharmais
Dr.dr.Hilman Tadjoedin, SpPD-KHOM
Medicine Netupitant 16-12-2019 17-12-2019 Closed NA
87 Protectivity And Safety Following Recombinant Hepatitis B Vaccine With Different Source Of Hepatitis B Bulk Compared To Hepatitis B (bio Farma) Vaccine In Indonesian Population PT Bio Farma
FK Universitas Diponegoro - RS Nasional Diponegoro Semarang
a. SD Negeri Bulusan
b. SMP Negeri 17 Semarang
Dr. Yetty Movieta Nency Sp.AK
 Vaccine Hepatitis B Vaccine 28-10-2019 30-10-2019 Closed NA
88 Studi Farmakokinetik Inaplant Susuk Satu Batang 150 Mg Yang Diproduksi Oleh Pt. Catur Dakwah Crane Farmasi, Indonesia Dibandingkan Dengan Sino-implant (ii) Susuk Dua Batang 2 X 75 Mg (150 Mg) Yang Diproduksi Oleh Shanghai Dahua Pharmaceuticals Co.ltd., Cina PT Catur Dakwah Crane Farmasi
RS Ibu Anak Kendangsari
Dr. Damayanti Rusli Sjarif, PhD, SpA(K)
 Medicine Inaplant 08-10-2019 09-10-2019 Closed NA
89 A Randomized Double Blind Placebo Controlled Trial Of Adjunctive Dexamethasone For The Treatment Of Hiv-infected Adults With Tuberculous Meningitis University of Oxford
 Eijkman Oxford Clinical Researh Unit (EOCRU)
FK Universitas Indonesia – RSUP Persahabatan
dr. Erlina Burhan, Sp.P
 Medicine Dexamethasone 22-07-2019 23-07-2019 Closed NA
90 Safety And Efficacy Of Early-start Deferiprone Treatment In Infants And Young Children Newly Diagnosed With Transfusion-dependent Beta Thalassemia ApoPharma Inc, Canada
 PT. IQVIA
Departemen Ilmu Kesehatan Anak, FK Universitas Indonesia – RSUPN Dr. Cipto Mangunkusumo
Dr.dr. Pustika Amalia Wahidiyat SpA(K)
 Medicine Deferiprone 16-07-2019 17-07-2019 Closed NA
91 Two-month Regimens Using Novel Combinations To Augment Treatment Effectiveness For Drug-sensitive Tuberculosis University College London
 PT. INC Research Indonesia
FK Universitas Hasanudin – RS. Wahidin Sudirohusodo Makassar
Dr.dr Irawaty Djaharuddin, Sp.P(K)
 Medicine TRUNCATE-TB 09-07-2019 10-07-2019 Closed NA
92 Two-month Regimens Using Novel Combinations To Augment Treatment Effectiveness For Drug-sensitive Tuberculosis University College London
 PT. INC Research Indonesia
FK Universitas Brawijaya – RSUD dr. Saiful Anwar
Dr.Yani Jane R. Sugiri, Sp.P(K)
 Medicine TRUNCATE-TB 29-04-2019 30-04-2019 Closed NA
93 Safety And Immunogenicity Of Vi-dt Typhoid Conjugate Vaccine (bio Farma) In Indonesian Adults, Adolescents, Children And Infants (phase Ii) PT. Bio Farma (Persero)
 PT. Prodia Diacro Laboratories
Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran Universitas Indonesia – RSCM
a. Puskesmas Jatinegara
b. Puskesmas Senen
dr. Bernie Endyarni Medise, SpA(K), MPH
 Vaccine Vi-DT Typhoid Conjugate Vaccine 13-03-2019 14-03-2019 Closed NA
Last Updated on : 05-06-2026 15:19