Informasi Umum

 

Uji Klinik adalah setiap penelitian dengan mengikutsertakan subjek manusia yang menerima suatu produk untuk menemukan atau memastikan efek klinik, farmakologi dan/atau untuk farmakodinamik lainnya, dan/atau mengidentifikasi setiap reaksi yang tidak diinginkan, dan/atau untuk mempelajari absorbsi, distribusi, metabolisme dan ekskresi untuk memastikan keamanan dan/atau efikasi produk yang diteliti. 

 

Regulasi Uji Klinik

 

Uji klinik yang diatur oleh Badan POM terdiri atas:

  1. Uji Klinik Pra Pemasaran: dilakukan terhadap produk uji yang belum memiliki izin edar di Indonesia atau uji klinik dengan produk uji yang telah memiliki izin edar dengan perubahan pada indikasi/klaim khasiat atau klaim manfaat, kombinasi, dan/atau posologi/aturan pakai.
  2. Uji Klinik Pasca Pemasaran: dilakukan terhadap produk uji yang telah memiliki izin edar di Indonesia untuk mendapatkan data keamanan dan/atau untuk konfirmasi khasiat/manfaat yang telah disetujui.

 

Uji klinik Pra Pemasaran dan Pasca Pemasaran wajib memperoleh Persetujuan Pelaksanaan Uji Klinik (PPUK) dari BPOM. Pelaksanaan uji klinik obat wajib mengacu pada pedoman CUKB sebagaimana tercantum dalam:

Peraturan Badan POM No. 8 Tahun 2024 tentang Tata Laksana Persetujuan Pelaksanaan Uji Klinik

Pengajuan PPUK

PPUK diajukan oleh Sponsor atau Organisasi Riset Kontrak (ORK) sebelum uji klinik dilaksanakan. PPUK diajukan secara elektronik melalui aplikasi SIAP-UK https://siap-uk.pom.go.id/ . Dalam hal aplikasi SIAP-UK terdapat kendala teknis, pengajuan PPUK dapat disampaikan melalui email clinicaltrial@pom.go.id .

 

Persyaratan Pengajuan PPUK 

Pengajuan PPUK disampaikan dengan melampirkan dokumen-dokumen sebagai berikut:

  1. Dokumen Uji Klinik
    • Protokol Uji Klinik
    • Informed Consent Form
    • Brosur Peneliti
    • Pernyataan Peneliti
    • Pernyataan Sponsor
    • CV dan Sertifikat Peneliti
    • Asuransi Subjek (bila ada)
    • Bukti Akreditasi Lab yang Ditunjuk
    • Letter of Authorization (LoA) dari Sponsor ke ORK (bila menggunakan ORK)
  2. Dokumen Produk Uji Klinik
    • Sertifikat Cara Pembuatan/ Produksi yang Baik
    • Summary Batch Protocol 3 batch berurutan (untuk produk biologi)
  3. Dokumen Pendukung Lainnya

 

Alur Pengajuan PPUK

PPUK diberikan setelah memperoleh persetujuan dari Komite Etik. Pengajuan PPUK ke BPOM dapat dilakukan secara paralel dengan pengajuan Persetujuan Etik

Berikut ini merupakan alur permohonan PPUK ke BPOM:

 


 

Biaya Pengajuan PPUK

Sponsor atau ORK melakukan pembayaran dengan nominal 5 (lima) juta rupiah dalam waktu paling lama 10 (sepuluh) hari kalender terhitung sejak SPB terbit.

 

Timeline Pengajuan PPUK

Hasil evaluasi uji klinik disampaikan dalam jangka waktu paling lama 20 (dua puluh) hari kerja sejak tanggal dilakukannya pembayaran menggunakan mekanisme time to respond.

Mekanisme time to respond yang dimaksud adalah sebagai berikut:

  1. perhitungan jangka waktu evaluasi dihentikan apabila berdasarkan hasil evaluasi memerlukan perbaikan dan/atau tambahan data
  2. perhitungan jangka waktu evaluasi dimulai kembali dari awal setelah Sponsor atau ORK menyampaikan perbaikan dan/atau tambahan data.  

 

Sponsor atau ORK menyampaikan perbaikan berdasarkan permintaan BPOM paling lama 100 (seratus) hari kerja sejak diterbitkannya permintaan.

 

Dalam kondisi kedaruratan kesehatan masyarakat yang ditetapkan oleh pemerintah, hasil evaluasi Uji Klinik untuk Obat yang digunakan dalam rangka penanggulangan kondisi kedaruratan kesehatan masyarakat diterbitkan paling lama 15 (lima belas) hari kerja.

 

 

Pelaporan Uji Klinik

Kejadian Tidak Diinginkan Serius (KTDS)

 

Kejadian Tidak Diinginkan Serius (KTDS) adalah setiap kejadian medis tidak diinginkan yang terjadi pada Uji Klinik, tanpa melihat adanya hubungan sebab akibat dengan Produk Uji yang mengakibatkan kematian, mengancam jiwa, memerlukan perawatan di rumah sakit, atau perpanjangan perawatan di rumah sakit, mengakibatkan cacat/ ketidakmampuan yang menetap atau bermakna atau mengakibatkan cacat bawaan/ cacat lahir.

KTDS wajib dilaporkan oleh Peneliti Utama kepada Sponsor dan Komite Etik, serta oleh Sponsor kepada BPOM sebagai berikut:

 

Efek Samping Produk Uji yang Serius

 

Efek samping Produk Uji yang serius merupakan respon yang berhubungan dengan suatu Produk Uji baik yang diduga maupun yang tidak diduga yang mengakibatkan kematian, mengancam jiwa, memerlukan perawatan di rumah sakit atau perpanjangan perawatan di rumah sakit, mengakibatkan cacat/ketidakmampuan yang menetap atau bermakna atau mengakibatkan cacat bawaan/cacat lahir yang terjadi pada dosis pencegahan, diagnosis atau terapi penyakit atau untuk modifikasi fungsi fisiologi.

Sponsor wajib melaporkan efek samping produk uji yang serius kepada BPOM sebagai berikut:

Sponsor juga harus melaporkan efek samping produk uji yang serius dan tidak diduga (yang belum tercantum dalam informasi produk) dari uji klinik di negara lain yang melibatkan sentra uji klinik di Indonesia kepada BPOM.

 

Pelaporan efek samping produk uji yang serius dilaporkan kepada BPOM dengan menggunakan format berikut: [Pdf] Formulir Pelaporan Efek Samping Produk Uji yang Serius. Selain menggunakan format formulir tersebut, Sponsor dapat menggunakan format pelaporan lain dengan memuat informasi paling sedikit yang mengacu pada formulir tersebut.

 

Laporan Pelaksanaan Uji Klinik 

 

Sponsor wajib menyampaikan laporan perkembangan pelaksanaan Uji Klinik kepada BPOM dengan ketentuan sebagai berikut:

  1. Setiap 6 (enam) bulan: disampaikan menggunakan format laporan berikut [Pdf] Format Laporan Pelaksanaan Uji Klinik Tiap 6 Bulan
  2. Pada saat berakhirnya pelaksanaan Uji Klinik: disampaikan paling lambat 30 hari kerja sejak berakhirnya pelaksanaan uji klinik menggunakan format laporan berikut [Pdf] Format Laporan Berakhirnya Pelaksanaan Uji Klinik
  3. Pada saat Uji Klinik dihentikan pelaksanaannya sebelum waktunya: disampaikan paling lambat 15 hari kerja sejak penghentian pelaksanaan uji klinik disertai dengan alasan penghentian menggunakan format laporan berikut [Pdf] Format Laporan Penghentian Pelaksanaan Uji Klinik



Laporan KTDS, Efek Samping Produk Uji yang Serius dan laporan Pelaksanaan Uji Klinik disampaikan kepada BPOM melalui email clinicaltrial@pom.go.id.

Inspeksi CUKB

Inspeksi CUKB adalah tindakan regulator/ Badan POM untuk melaksanakan pemeriksaan resmi terhadap dokumen, fasilitas, rekaman dan sumber lain yang dianggap oleh otoritas regulatori ada hubungannya dengan Uji Klinik (termasuk uji bioekivalensi), di Sentra Uji Klinik, Sponsor dan/atau di ORK, dan/atau di tempat lain yang berhubungan dengan pelaksanaan Uji Klinik. Inspeksi dilakukan secara rutin atau berdasarkan adanya kasus. Inspeksi dapat dilakukan sebelum/pada saat/setelah uji klinik dilaksanakan.

 

Pelaksanaan inspeksi bertujuan untuk: 

  • Memastikan uji klinik dilaksanakan sesuai dengan CUKB dan protokol yang disetujui 
  • Memastikan perlindungan terhadap subjek uji klinik 
  • Memastikan konsistensi data misal menilai kesesuaian informasi pada dokumen sumber dengan dokumen esensial 
  • Memastikan akuntabilitas obat uji klinik 

 

Inspeksi CUKB dilaksanakan oleh inspektur CUKB BPOM sebagai berikut:

BPOM dapat menunjuk personel lain berdasarkan kompetensi dan/atau keahliannya untuk melaksanakan inspeksi CUKB.

 

Tindak lanjut inspeksi CUKB dapat berupa pembinaan teknis dan/atau sanksi administratif.

 

Pembinaan Teknis

Pembinaan teknis adalah tindakan yang dilaksanakan BPOM dalam rangka memberikan pembinaan terhadap perbaikan dan pencegahan temuan hasil inspeksi. Peneliti Utama, Sponsor, dan/atau ORK wajib menyampaikan laporan tindakan perbaikan dan pencegahan/ Corrective Action Preventive Action (CAPA) dalam batas waktu paling lambat 20 (dua puluh) hari kerja terhitung sejak tanggal surat hasil inspeksi. 

Jika berdasarkan hasil evaluasi BPOM, laporan belum lengkap dan benar, maka BPOM akan menyampaikan permintaan perbaikan terhadap laporan CAPA. 

Peneliti Utama, Sponsor, dan/atau ORK wajib menyampaikan laporan paling banyak 2 (dua) kali dalam batas waktu paling lambat 20 (dua puluh) hari kerja untuk masing-masing perbaikan terhitung sejak tanggal surat permintaan BPOM. Jika hal ini tidak dipenuhi, maka dapat dikenakan sanksi administratif.

 

Sanksi Administratif

Sanksi administratif dapat berupa:

  1. Peringatan (jika Peneliti Utama, Sponsor, dan/atau ORK tidak melakukan dan melaporkan CAPA sesuai hasil inspeksi)
  2. Peringatan keras (jika tidak ada perbaikan terhadap sanksi peringatan sebelumnya)
  3. Penangguhan Uji Klinik (berdasarkan pengkajian terdapat pelanggaran terkait pelaksanaan Uji Klinik; dan/atau tidak ada perbaikan terhadap sanksi peringatan keras sebelumnya) dan/atau
  4. Penghentian pelaksanaan Uji Klinik (jika berdasarkan pengkajian terdapat pelanggaran terkait pelaksanaan Uji Klinik yang berdampak serius pada keselamatan Subjek Uji Klinik; berdasarkan pengkajian terdapat pelanggaran yang berdampak serius pada kredibilitas data Uji Klinik: dan/atau tidak ada perbaikan terhadap sanksi penangguhan Uji Klinik sebelumnya).

 

Data Keputusan Pengajuan PPUK

Klik pada Judul Protokol yang dipilih untuk mengakses Ringkasan Hasil Evaluasi

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No Judul Protokol Fase Ruang Lingkup Sponsor ORK Sentra Uji Klinik Peneliti Utama Jenis Produk Uji Nama Produk Uji Status Pengajuan Tanggal Keputusan Status Pelaksanaan
1 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
 Produk Biologi Factor VIII, Human Plasma Derived Disetujui 02-09-2025
2 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
 Produk Biologi MB12 Dibatalkan 21-08-2025 Tidak dilaksanakan
3 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 Lokal Daewoong Pharmaceutical Co.,Ltd
 PT Equilab International
RS Dr. Cipto Mangunkusumo
dr. Dicky Levenus Tahapary, Sp.PD-KEMD, PhD, FINASIM
 Obat Enavoglifozin/ Phentermine combination Dibatalkan 18-08-2025 Tidak dilaksanakan
4 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 Lokal 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
 Vaksin V181 Dengue Vaccine Disetujui 14-08-2025
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 I Lokal 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)
 Vaksin Vaccine Ad5-105K Disetujui 14-05-2025 Belum Dimulai
6 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
 Obat Methotrexate Disetujui 17-04-2025
7 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 Lokal 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
 Obat BGM0504 Disetujui 17-04-2025 Sedang berlangsung
8 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 Lokal 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)
 Produk Biologi RECOMBINANT MYCOBACTERIUM TUBERCULOSIS FUSION PROTEIN (EC) Disetujui 17-04-2025 Sedang berlangsung
9 Shortened Regimen For Drug-susceptible Tuberculosis In Children (smile-tb) III Lokal 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.
 Obat Rifapentin, Moxifloxacin, INH, Pirazinamide Disetujui 21-03-2025 Sedang berlangsung
10 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 Lokal Kementerian Kesehatan RI
Fakultas Kedokteran Universitas Hasanuddin
Prof. dr. Syafruddin, Ph.D
 Obat Dihydroartemisinin-Piperaquin, Artesunate-Pyronaridine, Artemether-Lumefantrine Disetujui 06-02-2025 Sedang berlangsung
11 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 Lokal Dongkook Pharmaceutical
 PT Equilab International
RSUD Dr. Soetomo
Dr. dr. Wahjoe Djatisoesanto, Sp.U(K)
 Obat Goserelin Acetate Disetujui 17-01-2025 Sedang berlangsung
12 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 Lokal 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
 Obat Microgest Dibatalkan 14-01-2025 Tidak dilaksanakan
13 Efikasi Analgetik Preemptif Ketamin Terhadap Nyeri Pasca Operasi Di Rsup Dr. Sardjito III Lokal dr. David Ferdiansyah
RSUP Dr. Sardjito
dr. David Ferdiansyah
 Obat Ketamine Hydrochloride Dibatalkan 06-01-2025 Tidak dilaksanakan
14 Efek Pemberian Phenylephrine Bolus Dengan Dosis Berbeda Untuk Mencegah Hipotensi Akibat Anestesispinal Pada Seksio Sesarea Di Rsup Dr.sardjito III Lokal 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
 Obat Phenylephrine Dibatalkan 31-12-2024 Tidak dilaksanakan
15 Phase 3, Double-blind, Placebo-controlled Study Of Recce®327 Topical Gel For The Treatment Of Diabetic Foot Ulcer Infections III Lokal Recce Pharmaceuticals Ltd.
 PT INCREASE LABORATORIUM INDONESIA
Siloam Hospitals Lippo Village (SHLV)
Prof. Dr. dr. Em Yunir, Sp.PD-KEMD
 Obat RECCE®327 Topical Gel Disetujui 04-12-2024 Belum Dimulai
16 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 Lokal Dongkook Pharmaceutical
 Equilab International
RSUD Dr. Soetomo
Dr. dr. Wahjoe Djatisoesanto, Sp.U(K)
 Obat Gosereline Acetate Dibatalkan 19-11-2024 -
17 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.
 Vaksin PCV Disetujui 01-10-2024 Sedang berlangsung
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 I Lokal 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
 Vaksin Vaksin VLP-Polio Disetujui 01-10-2024 Sedang berlangsung
19 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
 Obat Triple Artemisinin Dibatalkan 29-08-2024 Tidak dilaksanakan
20 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 Lokal 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.
 Obat Fexuprazan Disetujui 23-07-2024 Sedang berlangsung
21 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
 Produk Biologi Serplulimab Disetujui 14-07-2024 Sedang berlangsung
22 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
 Produk Biologi Efesa (Efepoetin Alfa) Disetujui 24-05-2024 Sedang berlangsung
23 Safety And Immunogenicity Of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally And Intramuscularly Via Needle-free Injection System II Lokal PharmaJet
 PT Prodia Diacro Laboratories
Departemen Kesehatan Anak FK Universitas Padjadjaran
Prof. Cissy B Kartasasmita
 Vaksin Vaksin gardasil viaPHARMAJET Tropis and Stratis Needle Free Injection System Dibatalkan 25-04-2024 Tidak dilaksanakan
24 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
 Vaksin M72/AS01E-4 Disetujui 19-04-2024 Sedang berlangsung
25 Pengaruh Pemberian Melatonin 20 Mg Terhadap Perubahan Nilai Limfosit Absolut, Rasio Neutrofil-limfosit Dan Kadar Prokalsitonin Pada Pasien Sepsis Dan Syok Sepsis III Lokal dr Vick Elmore Simanjuntak Sp An
RSUP Fatmawati
dr Vick Elmore Simanjuntak Sp An
 Obat Melatonin Disetujui 22-03-2024 Sedang berlangsung
26 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
 Obat Bemnifosbuvir Dibatalkan 21-03-2024 -
27 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
 Obat Bemnifosbuvir dan Ruzasvir Disetujui 28-02-2024 Dibatalkan
28 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 Lokal PT Biotis
RSUD Dr. Soetomo, Surabaya
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
 Vaksin Inavac Disetujui 20-11-2023 Selesai
29 Immunogenicity Of 23-valent Pneumococcal Polysaccharide Vaccine In Older Adults IV Lokal MERCK SHARP & DOHME INDONESIA
 Prodia DiaCRO Laboratories
Rumah Sakit Cipto Mangunkusumo
DR.dr. Kuntjoro Harimurti, Sp.PD. K-Ger
 Vaksin Pneumovac-23 Dibatalkan 03-11-2023
30 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 Lokal PT. Taisho
 Prodia DiaCRO Laboratories
Siloam Hospital
Dr. Yogi Prawira, Sp.A (K)
 Obat Tempra forte Ditolak 26-10-2023 -
31 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)
 Vaksin Menhycia Disetujui 26-10-2023 Sedang berlangsung
32 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
 Vaksin HPV Disetujui 29-09-2023 Sedang berlangsung
33 Safety Profile Of Booster Indovac Covid-19 Vaccination In Healthy Populations Aged 18 Years And Above IV Lokal 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
 Vaksin Indovac Dibatalkan 27-09-2023
34 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 Lokal 1.Kemenkes RI
2.Unair
3.PT Biotis
RSUD Dr. Soetomo, Surabaya
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
 Vaksin Vero Cell Inactivated Dibatalkan 14-09-2023 -
35 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 Lokal 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)
 Vaksin PCV13-TT Disetujui 13-09-2023 Sedang berlangsung
36 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)
 Obat Kombinasi Rifapentine dan Isoniazid Disetujui 13-09-2023 Sedang berlangsung
37 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 Lokal 1.Badan Kebijakan Pembangunan Kesehatan
2.Universitas Airlangga
3.PT Biotis
RSUD. Dr. Soetomo, Surabya
Dr. Dominicus Husada, dr., SpA(K)
 Vaksin Inavac Disetujui 13-09-2023 Sedang berlangsung
38 A Prospective, Multicenter, Single-arm Clinical Study Evaluating The Use Of Ucmsc Secretome For Dermal Resurfacing III Lokal PT Bifarma Adiluhung
RSUPN Dr. Cipto Mangunkusumo
dr. Sondang MHA Pandjaitan Sirait, SpKK(K), MPd.Ked, FINSDV, FAADV
 Produk Biologi Secretom dermal Dibatalkan 24-07-2023 -
39 Immunogenicity & Safety Of Indovac As A Homologous Booster Dose Against Covid-19 In Adults Aged 18 Years And Above In Indonesia III Lokal PT Bio Farma
 PT Equilab International
Fakultas Kedokteran Universitas Diponegoro
dr. Yetty Movieta Nency, Sp.A.(K)
 Vaksin IndoVac Disetujui 18-07-2023 Selesai
40 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 Lokal 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)
Obat Ovine Enoxaparin Disetujui 27-06-2023 Selesai
41 Safety And Immunogenicity Of Indovac® In Healthy Children Aged 6-11 Years In Indonesia II Lokal PT Bio Farma
 PT Equilab International
Fakultas Kedokteran Universitas Diponegoro, Semarang
dr. Yetty Movieta Nency, Sp.A (K)
 Vaksin IndoVac Dibatalkan 19-05-2023 -
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 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
 Vaksin HPV Ditolak 03-05-2023 -
43 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 Lokal 1.Badan Kebijakan Pembangunan Kesehatan
2.Universitas Airlangga
3.PT Biotis
RSUD. Dr. Soetomo, Surabya
Dr. Dominicus Husada, dr., SpA(K)
 Vaksin Inavac Disetujui 26-04-2023 Selesai
44 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). IV Lokal University of Otago
Research Center for Care and Control Infectious Disease Universitas Padjadjaran
dr. Lika Apriani, MSc, Ph.D
 Vaksin Vaksin BCG Kering Disetujui 21-03-2023 Selesai
45 Immunogenicity And Safety Of Indovac® As A Heterologous Booster Dose Against Covid-19 In Children 12-17 Years Of Age II Lokal 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
 Vaksin IndoVac Disetujui 13-02-2023 Selesai
46 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 Lokal 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)
 Vaksin Vaksin Merah Putih (Vero Cell Inactivated) Dibatalkan 06-02-2023 -
47 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 Lokal 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)
 Vaksin Vaksin Merah Putih (Vero Cell Inactivated) Dibatalkan 06-02-2023 -
48 Profil Keamanan Diphtheria Antitoxin (dat) Di Indonesia IV Lokal PT Bio Farma
RSUD Dr. Soetomo, Surabaya
Dr. Dominicus Husada, dr., SpA(K)
 Obat Diphtheria Antitoxin B.P Disetujui 25-01-2023 Selesai
49 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
 Vaksin mRNA SARS-COV-2 Omicron BA 4/5 Disetujui 18-01-2023 Sedang berlangsung
50 Immunogenicity And Safety Following In-house Recombinant Hepatitis B (bio Farma Vaccine Compared To Hepatitis B (bio Farma) Vaccine In Indonesian Population III Lokal PT. Bio Farma
RSUP Prof. I.G.N.G Ngoerah
Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)
 Vaksin Hepatitis B Disetujui 15-11-2022 -
51 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 Lokal 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)
 Vaksin Indovac Disetujui 30-09-2022 Selesai
52 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.
 Obat Proxalutamide Disetujui 12-09-2022 Dihentikan dini
53 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 Lokal 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)
 Vaksin Vaksin SARS-CoV-2 -PT. Bio Farma ajuvan alum CPG Disetujui 30-08-2022 Selesai
54 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 Lokal 1.Kemenkes RI
2.PT. Biotis
3.Universitas Airlangga
RSUD Dr. Soetomo, Surabaya
Dr. dr. Dominicus Husada, DTM&H., MCTM(TP).,SpA(K)
 Vaksin Vaksin Merah Putih (Vero Cell Inactivated) Disetujui 26-08-2022 Selesai
55 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 Lokal Departemen Farmakologi UGM
 PT Equilab International
Departemen Farmakologi UGM
dr. Dwi Aris Agung Nugrahaningsih, M.Sc., Ph.D.
 Obat AD17002 / Heat Labile E Coli Disetujui 18-07-2022 Sedang berlangsung
56 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
 Obat hzVSF-v13 Disetujui 27-06-2022 Selesai
57 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 Lokal 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
 Vaksin Vaksin Merah Putih (Vero Cell Inactivated) Disetujui 24-06-2022 Selesai
58 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 Lokal 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)
 Vaksin Vaksin SARS-CoV-2 -PT. Bio Farma Disetujui 06-06-2022 Selesai
59 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
 Vaksin Vaksin SARS CoV-2 mRNA Variant Omicron dan Delta Disetujui 02-06-2022 Selesai
60 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
 Produk Biologi Anti-coronavirus Hyperimmune Intravenous lmmunoglobulin Disetujui 02-06-2022 Dihentikan dini
61 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 Lokal 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)
 Obat Metformin XR Disetujui 28-04-2022 Sedang berlangsung
62 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
 Vaksin Inactivated Booster Dibatalkan 27-04-2022 -
63 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 Lokal 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)
 Vaksin Vaksin SARS-CoV-2 -PT. Bio Farma ajuvan alum CPG Disetujui 11-04-2022 Selesai
64 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
 Vaksin Vaksin COVID-19 Intranasal (Viral Vector) Ditolak 22-02-2022 -
65 Stop Transmisi Kusta Pep++ III Global NLR Indonesia
RSUD Dr. Soetomo, Surabaya
Prof. Dr. dr. Cita Rosita Sigit Prakoeswa
 Obat Rifampicin, Klaritromicin Disetujui 22-02-2022 Dibatalkan
66 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 Lokal 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)
 Vaksin Vaksin SARS-CoV-2 -PT. Bio Farma ajuvan alum CPG Disetujui 14-02-2022 Selesai
67 Safety And Immunogenicity Of Unair Inactivated Covid-19 Vaccine In Healthy Population Aged 18 Years And Above (phase I/ii) I/II Lokal 1.Kemenkes RI
2.PT. Biotis
3.UNAIR
RSUD Dr. Soetomo, Surabaya
Dr. Dominicus Husada, dr., Sp.A(K)
 Vaksin UNAIR Inactivated Covid-19 Vaccine Disetujui 05-02-2022 Selesai
68 Immunogenicity And Safety Study Of Half Dose Of Moderna Covid-19 Vaccine Booster Heterologous In Adult Subjects In Indonesia III Lokal Badan Litbangkes, Kementerian Kesehatan RI
FK Universitas Indonesia
a. Puskesmas Cempaka Putih
dr. Nina Dwi Putri, Sp.A(K).
 Vaksin Vaksin Booster Moderna Disetujui 02-02-2022 Selesai
69 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
 Vaksin Recombinant Novel Coronavirus Vaccine Dibatalkan 31-01-2022
70 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
 Obat RUTI Disetujui 27-01-2022 Dibatalkan
71 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 Lokal PT Etana Biotechnologies Indonesia
 CRSU FKUI
Rumah Sakit Kanker Dharmais
dr. Ronald Alexander Hukom, Sp.PD, KHOM, MHSC, FINASIM
 Obat Bevacizumab Disetujui 21-01-2022 Dihentikan dini
72 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
 Obat Niclosamide Disetujui 05-01-2022 Dihentikan dini
73 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 Lokal 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
 Vaksin SARS-COV-2 Vaccine (Vero Cell) Inactivated Disetujui 28-12-2021 Selesai
74 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
 Vaksin SARS-CoV-2 Fusion Protein Vaccine (V-01) Ditolak 28-12-2021
75 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 Lokal 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)
 Vaksin SARS-CoV-2 Protein Subunit Recombinant Vaccine Disetujui 06-12-2021 Selesai
76 Uji Klinik Fase Iii, Acak, Terbuka Pemberian Terapi Tambahan Bamlanivimab-etesevimab Pada Pasien Covid-19 Derajat Ringan Sedang III Lokal 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
 Obat Bamlanivimab -Etesevimab Disetujui 06-12-2021 Selesai
77 Safety And Tuberculin Conversion Following Bcg Vaccine Vial (bio Farma) Compared To Registered Bcg Vaccine (bio Farma) In Indonesian Infants” II Lokal PT Bio Farma
Departemen Ilmu Kesehatan Anak RSUD Dr. Soetomo Surabaya
Dr. Dominicus Husada, dr., Sp.A(K)
 Vaksin Vaksin BCG Disetujui 22-11-2021 Selesai
78 Studi Klinis Fase Iii, Acak, Tersamar Ganda, Terkontrol Plasebo Untuk Mengevaluasi Efikasi Dan Keamanan Proxalutamide (gt0918) Pada Pasien Rawat Inap Covid-19 III Lokal 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
 Obat Proxalutamide Disetujui 19-11-2021 Dihentikan dini
79 Immunogenicity And Safety Study Of Half And Full Doses Of Heterologous And Homologous Covid19 Vaccine Booster In Adult Subjects In Indonesia. II Lokal 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)
 Vaksin Sinovac, AstraZeneca, Pfizer Disetujui 17-11-2021 Selesai
80 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
 Vaksin SARS-CoV-2 Fusion Protein Vaccine Disetujui 19-10-2021 Sedang berlangsung
81 Perbandingan Deksamethasone Dosis Tinggi Dan Dosis Standar Pada Anak Dengan Covid-19 Derajat Sedang Berat: Uji Klinis Acak Tersamar Ganda Multisenter (sterco Trial) III Lokal 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
 Obat Deksamethasone Disetujui 15-10-2021 Dibatalkan
82 The Effect Of Incremental Continuous Ambulatory Peritoneal Dialysis On The Preservation Of Residual Kidney Function And Clinical Outcomes: A Randomized Controlled Trial (icodextrin) IV Lokal Prodia Diacro Laboratories
RSUPN Dr. Cipto Mangunkusumo
dr. Aida Lydia, PhD, SpPD,KGH
 Obat Icodextrin Disetujui 08-10-2021 Dihentikan dini
83 Efek Terapi Anti Interleukin-6 Tocilizumab Terhadap Outcome Pasien Covid-19 Derajat Berat III Lokal Balitbangkes, Kemenkes
RS Dustira, Cimahi
Dr. dr. Arief Kurniawan, SpAn, KIC, MMRS, FISQua
 Obat Tocilizumab Disetujui 08-10-2021 Selesai
84 "efikasi Dan Keamanan Imunoglobulin Intravena ( Ivig ) Pada Pasien Covid-19 Sedang Dan Berat" III Lokal 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
 Produk Biologi IVIG Disetujui 04-10-2021 Dibatalkan
85 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 Lokal Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUP Dr. Sardjito
dr. Ika Trisnawati Sp.PD,KP
Obat Tocilizumab Disetujui 03-10-2021 Dibatalkan
86 “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) 
 Obat Tafenoquine, Primaquine Disetujui 13-09-2021 Sedang berlangsung
87 "efek Durasi Pemberian Remdesivir Terhadap Waktu Perbaikan Klinis Dan Keamanan Pada Pasien Covid-19 Usia Lanjut Derajat Sedang-berat'' III Lokal Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUPN Dr. Cipto Mangunkusumo
Dr. dr. Kuntjoro Harimurti, SpPD,KGer, M.Sc.
 Obat Remdesivir Disetujui 13-09-2021 Dibatalkan
88 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 Lokal Addimune Coorperation Taiwan
 PT IQVIA RDS Indonesia
RSA Universitas Gadjah mada
dr. Astari Pranindya Sari, M.Sc.,
 Vaksin Adimrsc-2f Disetujui 08-09-2021 Selesai
89 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
Obat Novaferon Disetujui 30-08-2021 Dibatalkan
90 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)
Vaksin Vaksin mRNA Disetujui 27-08-2021 Selesai
91 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
Obat Ensovibep (MP0420) Disetujui 25-08-2021 Dihentikan dini
92 Studi Efikasi Dan Keamanan Terapi Intravenous Imunoglobulin Pada Pasien Covid-19 Derajat Berat Dibandingkan Standard Of Care III Lokal Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSPI Prof. Dr. Sulianti Saroso
dr. Adiatmo Pratomo, Sp.PD
Produk Biologi IVIG Disetujui 27-07-2021 Dibatalkan
93 Efikasi Dan Keamanan Remdesivir Pada Pasien Covid 19 Derajat Sedang Berat Di Rsup Dr. M.djamil III Lokal Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUP Dr. M. Djamil Padang
dr. H. Irvan Medison, SpPK, FIRS, FAPSR
Obat Remdesivir Disetujui 21-07-2021 Dibatalkan
94 Intravenous Immunoglobulin (ivig) Sebagai Terapi Pasien Covid-19: Sebuah Uji Klinis III Lokal 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
 Produk Biologi IVIG Disetujui 12-07-2021 Dibatalkan
95 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
 Vaksin Vaksin SF9 Disetujui 07-07-2021 Sedang berlangsung
96 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
Vaksin GX-19N Disetujui 05-07-2021 Dibatalkan
97 Safety And Immunogenicity Of covid-19 vaccine In Healthy Adults Aged 60 Years And Above In Indonesia III Lokal PT. Bio Farma
Departemen Ilmu Kesehatan Anak FK Universitas Airlangga - RSUD Dr. Soetomo
Dr. Dominicus Husada, dr., SpA(K)
 Vaksin Sinovac Dibatalkan 01-07-2021
98 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 Lokal 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)
Obat Ivermectin Disetujui 27-06-2021 Dihentikan dini
99 The Use Of Systemic Corticosteroids In Moderate To Critical Ill Patients With Covid-19 III Lokal Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RS Soetomo, Surabaya
dr Irmi Syafa'ah, Sp.P(K)
 Obat Dexamethasone Disetujui 21-06-2021 Dibatalkan
100 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 Lokal Puslitbang Sumber Daya dan Pelayanan Kesehatan, Badan Litbangkes Kemenkes RI
RSUP Persahabatan
Dr. dr. Erlina Burhan, MSc, SpP(K)
Obat Remdesivir Disetujui 21-06-2021 Dibatalkan
101 Uji Klinik Kegunaan Dan Keamanan Terapi Exosome-msc (eksosom Yang Diproses Dari Sel Punca Mesenkimal) Untuk Meredakan Hiperinflamasi Pada Pasien Covid-19 I Lokal 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
 Produk Biologi Exosome-MSC Disetujui 18-06-2021 Dihentikan dini
102 Safety Profile Following Inactivated Covid-19 Vaccine In Healthy Adults Aged >18 Years In Indonesia IV Lokal PT Bio Farma
Puskesmas di Jakarta
Dr. Julitasari Sundoro, dr., MSc-PH
 Vaksin Inactivated Covid-19 Vaccine Disetujui 02-06-2021
103 Uji Klinik Kegunaan Dan Keamanan Terapi Exosome-msc (eksosom Yang Diproses Dari Sel Punca Mesenkimal) Untuk Meredakan Hiperinflamasi Pada Pasien Covid-19 I Lokal 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
 Produk Biologi Exosome-MSC Disetujui 08-03-2021 Dihentikan dini
104 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
 Vaksin GX-19 PLASMA DNA Dibatalkan 26-02-2021
105 Serological Screen And Treat Trial For P.vivax : A-proof Of-conce-pt Trial In Eastern Indonesia III Lokal 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,
Obat Disetujui 23-02-2021
106 Randomised Evaluation Of Covid-19 Therapy (recovery) III Lokal 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
 Obat Colcisin, Dexamethasone, Empaglifozine Disetujui 18-02-2021 Sedang berlangsung
107 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 Lokal 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
 Vaksin Vaksin Zifivax Disetujui 03-02-2021 Selesai
108 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 Lokal 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
 Produk Biologi UCMSC Disetujui 30-12-2020
109 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
 Produk Biologi GX I7 Disetujui 29-12-2020
110 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 Lokal 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
 Obat Kuinin Sulfat Disetujui 10-12-2020
111 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
 Produk Biologi Anticoronavirus Immunoglobulin Disetujui 08-12-2020
112 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 Lokal 1.PT. AIVITA Biomedika Indonesia
2.Badan Penelitian dan Pengembangan Kesehatan
RSUP Dr. Kariadi
Dr.dr. Muchlis Achsan Udji, SpPD-KPTI, FINASIM
 Produk Biologi Sel Dendritik Disetujui 02-12-2020
113 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
 Produk Biologi hzVSFv13 Disetujui 01-12-2020
114 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
 Produk Biologi HLX-10 Disetujui 01-12-2020
115 Evaluasi Pemberian Remdesivir Pada Pasien Covid-19 Di Rsup Persahabatan Jakarta III Lokal PT. Amarox Pharma Global
RSUP Persahabatan
Dr. dr. Erlina Burhan, MSc, Sp.P (K)
 Obat Remdesivir Disetujui 01-12-2020
116 Persistence And Long Term Protection Of Vi Antibodies Induced By Vi-dt Conjugate Vaccines In Indonesian Adults, Adolescents, Children And Infants II Lokal PT. Bio Farma
Departemen Ilmu Kesehatan Anak FK Universitas Indonesia
a. Puskesmas Jatinegara
b. Puskesmas Senen
dr. Bernie Endyarni Medise, SpA(K), MPH
 Vaksin Vi-DT Conjugate Disetujui 10-11-2020
117 Efficacy, Safety Dan Immunogenecity Of Rotavirus Rv3 Vaccine(biofarma) In Neonates, Lot To Lot Consistency And Antigen Interference With Co-administeres Epi Vaccines III Lokal PT. Bio Farma
 IQVIA Indonesia
Center for Child Health Universitas Gadjah Mada
 dr. Jarir At-Thobari, PhD

Dr.dr. Titis Widowati, Sp.A(K)
 Vaksin Rotavirus Disetujui 07-10-2020
118 Fase Iii, Acak – Terbuka, Uji Klinis Efikasi Dan Keamanan Favipiravir Pada Pasien Covid-19 Di Indonesia III Lokal 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)
 Obat Favipiravir Disetujui 07-10-2020
119 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
 Obat Remdesivir Dibatalkan 29-09-2020
120 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)
 Vaksin Sinopharm Dibatalkan 29-09-2020
121 Reducing The Risk Of Plasmodium Vivax Relapse After Acute Plasmodium Falciparum Malaria In Co-endemic Areas - A Randomized Controlled Trial (prima) III Lokal Menzies School of Health Research, Australia
 EIJKMAN-Oxford Clinical Research Unit
FK Universitas Indonesia
a. Puskesmas Mangili
Prof. dr. Inge Sutanto, MPhil, SpPar(K)
 Obat Primaquine Disetujui 28-09-2020
122 Efficacy, Safety Dan Immunogenecity Of Rotavirus Rv3 Vaccine(biofarma) In Neonates, Lot To Lot Consistency And Antigen Interference With Co-administeres Epi Vaccines III Lokal 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)
 Vaksin Rotavirus Disetujui 18-09-2020
123 Aplikasi Sel Punca Mesenkimal Asal Tali Pusat Sebagai Terapi Adjuvan Pada Pasien Pneumonia Covid-19 Kritis III Lokal 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
 Produk Biologi Sel Punca Mesenkimal Disetujui 13-08-2020
124 High Dose Oral Rifampicin To Improve From Adult Tuberculosis Meningitis (harvest) III Lokal 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)
 Obat Rifampicin Disetujui 03-08-2020
125 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 Lokal PT. Bio Farma
RSUP Dr. Hasan Sadikin-FK Unpad
Prof. Dr. Kusnandi Rusmil, dr., Sp.A(K)., MM
 Vaksin Sinovac Disetujui 27-07-2020
126 Studi Terapeutik Evaluasi Efikasi Dan Keamanan Dw-msc Pada Pasien Covid-19: Studi Acak, Tersamar Ganda, Dan Terkontrol Plasebo I/II Lokal PT. Daewoong Infion
RSUP Dr. Wahidin Sudirohusodo, Makassar
dr. Irawaty Djaharuddin, Sp.P (K)
 Produk Biologi DW-MSC Disetujui 24-07-2020
127 Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan Covid 19 II/III Lokal BKPK Kemenkes RI
28 Rumah Sakit
Prof. David Hanjono Muljono, SpPD, PhD
 Produk Biologi Plasma convalescent Disetujui 20-07-2020
128 Chloroquine/ Hydroxychloroquine Prevention Of Coronavirus Disease (covid-19) In The Healthcare Setting; A Randomised, Placebo-controlled Prophylaxis Study (copcov) III Lokal 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
 Obat Chloroquine/Hydroxychloroquine Disetujui 15-07-2020
129 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 Lokal 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.
 Obat Kombinasi Disetujui 03-07-2020
130 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
 Obat BDB-001 Disetujui 15-06-2020
131 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 Lokal 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
Produk Biologi Plasma convalescent Disetujui 11-05-2020
132 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 Lokal PT. Bio Farma
FK Universitas Padjadjaran - RS Hasan Sadikin
Dr. Eddy Fadlyana, dr., Sp.A(K)., M.Kes
 Vaksin DPT HB Hib Disetujui 13-04-2020
133 Uji Klinik Favipiravir (avigan) Untuk Pengobatan Pada Pasien Covid 19 Di Beberapa Rumah Sakit Rujukan Covid 19 Di Jakarta III Lokal 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
 Obat Favipiravir Disetujui 10-04-2020
134 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
 Obat Solidarity Trial Disetujui 05-04-2020
135 Dosisi Tinggi Rifampisin 2 Bulan Versus Dosis Standar Rifampisin 4 Bulan Untuk Pengobatan Infeksi Laten Tb (iltb) : Sebuah Uji Klinik (2r2) II Lokal McGill International TB Centre, Canada
RS Pendidikan Universitas Padjajaran
Prof. Rovina Ruslami., dr., SpPD, PhD
 Obat Rifampicin Disetujui 16-03-2020
136 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
 Produk Biologi Efepoetin Alfa Disetujui 13-03-2020
137 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 Lokal PT. Tunggal Idaman Abdi
 PT. Equilab International
Pusat Pelatihan Olahraga Pelajar (PPOP) Clinic
a. Indonesia Sports Medicine Centre (ISMC)
dr. Zeth Boroh, Sp.KO
 Obat Diclofenac + Heparin Disetujui 09-03-2020
138 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,
Produk Biologi Adrecizumab Disetujui 09-03-2020
139 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 Lokal 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)
 Vaksin Typhoid Conjugate Vaccine Disetujui 20-01-2020
140 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
Obat Hyalofast Disetujui 06-01-2020
141 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 Lokal 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
 Produk Biologi Sansulin Disetujui 20-12-2019
142 Efficacy And Safety Of Peg 3350 For Treatment Of Chronic Constipation I Lokal PT. Meiji Indonesia Pharmaceutical Industries
RSUPN Dr. Cipto Mangunkusumo
Prof. Dr, dr. Murdani Abdullah, SpPD-KGEH
 Obat Macrogol 3350/ PEG Disetujui 28-11-2019
143 Safety And Preliminary Of Immunogenicity Following Recombinant Hepatitis B (biofarma) Vaccine In Adults & Children I Lokal PT. Bio Farma
RSUP Dr. Hasan Sadikin
Prof. Dr. Kusnandi Rusmil, dr., Sp.A(K)., MM
 Vaksin Vaksin Hepatitis Disetujui 18-11-2019 Selesai
144 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 Lokal Daewoong Pharmaceutical., Co., Ltd
 PT. Equilab International
RSPAD Gatot Soebroto
dr. Jonny Sp.PD-KGH,M.Kes, MM
 Produk Biologi Epodion Disetujui 18-11-2019
145 Pharmacodynamic Equivalence Of Ovine Enoxaparin To Porcine Enoxaparin (lovenox®) In Healthy Volunteers I Lokal PT. Metiska Farma
PT. Pharma Metric Labs
Prof. Arini Setiawati, PhD
 Obat Ovine Enoxaparin Disetujui 19-08-2019 Selesai
146 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 Lokal Mundipharma Laboratories GmBH
 PT. Prodia Diacro Laboratories
Rumah Sakit Kanker Dharmais
Dr.dr.Hilman Tadjoedin, SpPD-KHOM
 Obat NEPA Disetujui 19-08-2019
147 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)
 Vaksin Measles-Rubella (MR) Vaccine Disetujui 19-08-2019
148 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
 Obat Dolutegravir Disetujui 12-08-2019
149 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 Lokal PT. Bio Farma
Fakultas Kedokteran Universitas Diponegoro
Dr. Yetty Movieta Nency Sp.AK
 Vaksin Vaksin Hepatitis B Disetujui 18-07-2019 Selesai
150 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
 Produk Biologi Adrecizumab Disetujui 08-07-2019
151 Phase 3 Study Of Sfpp In Knee Osteoarthritis : A Randomized Controlled Study Using Diclofenac Gel As The Comparator III Lokal 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
 Obat S-Flurbiprofen Plaster (SFPP) Disetujui 10-06-2019
152 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
 Obat Linezolid Disetujui 28-05-2019
153 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
 Vaksin Sanaria PfSPZ Vaccine Disetujui 10-05-2019 Selesai
154 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 Lokal 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)
 Obat Cyclofem /Cyclonate Disetujui 22-04-2019
155 Dia - Ramadan Observational Study Program Assessing Effectiveness And Tolerability Of Gliclazide Mr 60 Mg In Patients With Type 2 Diabetes Fasting During Ramadan IV Lokal 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
 Obat Gliclazide Disetujui 04-04-2019
156 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)
 Produk Biologi Standard Treatment Antituberculosis (MDR-TB) Disetujui 19-03-2019
157 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
 Obat Deferiprone Disetujui 04-01-2019
158 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 Global PT. Merck Sharp and Dohme Indonesia
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No Judul Protokol Uji Klinik Sponsor ORK Sentra Uji Klinik Peneliti Utama Jenis Produk Uji Nama Produk Uji Tanggal Mulai Pelaksanaan Tanggal Selesai Pelaksanaan Status CAPA Tindakan Regulator
1 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
 Vaksin M72/AS01E-4 11-08-2025 12-08-2025 Dalam Proses Pemenuhan NA
2 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)
 Vaksin VLP-Polio 07-08-2025 08-08-2025 Dalam Proses Pemenuhan NA
3 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
 Obat Serplulimab 21-07-2025 22-07-2025 Dalam Proses Pemenuhan NA
4 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
 Produk Biologi Efepoetin Alfa 17-07-2025 18-07-2025 Dalam Proses Pemenuhan NA
5 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)
 Vaksin M72/AS01E-4 07-05-2025 08-05-2025 Dalam Proses Pemenuhan NA
6 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)
 Vaksin PCV13-TT 06-05-2025 08-05-2025 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, Co., Ltd. Indonesia
RSUPN Dr. Cipto Mangunkusumo
dr. Nina Dwi Putri, Sp.A SubsIPT (K), MSc
 Vaksin VLP-Polio 29-04-2025 30-04-2025 Closed NA
8 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.
 Vaksin Pneuminvac 21-04-2025 22-04-2025 Closed NA
9 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
 Obat Serplulimab 19-03-2025 20-03-2025 Closed NA
10 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
 Produk Biologi Efepoetin Alfa 17-03-2025 18-03-2025 Dalam Proses Pemenuhan NA
11 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
 Vaksin VLP-Polio 26-02-2025 27-02-2025 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 Indonesia
RSUP Prof. Dr. I.G.N.G Ngoerah, Denpasar
Dr. dr. I Made Gede Dwi Lingga Utama, Sp.A (K)
 Vaksin VLP-Polio 23-01-2025 24-01-2025 Closed NA
13 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
 Vaksin VLP-Polio 09-12-2024 10-12-2024 Closed NA
14 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
 Vaksin M72/AS01E-4 02-12-2024 03-12-2024 Closed NA
15 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
 Vaksin VLP-Polio 02-12-2024 03-12-2024 Closed NA
16 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)
 Vaksin M72/AS01E-4 28-11-2024 29-11-2024 Closed NA
17 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
 Vaksin M72/AS01E-4 25-11-2024 26-11-2024 Closed NA
18 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)
 Vaksin HPV 17-10-2024 18-10-2024 Closed NA
19 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)
 Obat Rifapentine & Isoniazid 23-07-2024 24-07-2024 Closed NA
20 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)
 Vaksin PCV13-TT 27-06-2024 28-06-2024 Closed Peringatan
21 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)
 Vaksin MCV (CRM197) 07-05-2024 08-05-2024 Closed NA
22 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)
 Vaksin PCV13-TT 29-04-2024 30-04-2024 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
RSU Universitas Muhammadiyah Malang
Prof. Dr. dr. Djoni Djunaedi, Sp.PD, KPTI
 Vaksin Vaksin HPV 07-03-2024 08-03-2024 Closed NA
24 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)
 Obat Enoxaparin 25-01-2024 26-01-2024 Closed NA
25 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)
 Vaksin Vaksin Inavac 07-12-2023 08-12-2023 Closed NA
26 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
 Obat Icodextrin 30-11-2023 01-12-2023 Closed NA
27 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)
 Vaksin Vaksin Indovac 23-11-2023 24-11-2023 Closed NA
28 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
 Obat AD17002 18-09-2023 19-09-2023 Closed NA
29 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
 Obat Rifampicin 27-07-2023 28-07-2023 Closed NA
30 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)
 Vaksin Vaksin Inavac 26-06-2023 27-06-2023 Closed NA
31 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
 Vaksin Vaksin Indovac 29-05-2023 30-05-2023 Closed NA
32 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
Vaksin Vaksin mRNA 10-05-2023 12-05-2023 Closed NA
33 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
 Vaksin Vaksin mRNA 20-03-2023 21-03-2023 Closed NA
34 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
 Obat Bevacizumab 20-02-2023 21-02-2023 Closed NA
35 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
 Produk Biologi Efepoetin Alfa 31-01-2023 01-02-2023 Closed Peringatan
36 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)
 Vaksin Vaksin Rotavirus 25-01-2023 26-01-2023 Closed NA
37 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
 Vaksin Vaksin IndoVac 13-12-2022 14-12-2022 Closed NA
38 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)
 Vaksin Vaksin IndoVac 01-12-2022 02-12-2022 Closed NA
39 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
 Produk Biologi GX-I7 23-11-2022 24-11-2022 Closed
40 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)
 Vaksin Vaksin mRNA 16-11-2022 18-11-2022 Closed NA
41 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)
 Vaksin Indovac 27-10-2022 28-10-2022 Closed NA
42 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
 Vaksin SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO-CoV.617.2) 19-10-2022 21-10-2022 Closed NA
43 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
 Vaksin Vaksin IndoVac 13-10-2022 14-10-2022 Closed NA
44 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
 Obat Rifampicin 29-09-2022 30-09-2022 Closed NA
45 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
 Vaksin Inavac 22-09-2022 23-09-2022 Closed Peringatan
46 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
 Vaksin Sanaria® PfSPZ Vaccine,Sanaria® PfSPZ-CVac 01-09-2022 02-09-2022 Closed NA
47 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)
 Vaksin Vaksin IndoVac 18-07-2022 19-07-2022 Closed NA
48 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
 Obat Dolutegravir,Darunavir 14-07-2022 15-07-2022 Closed NA
49 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
 Obat Proxalutamide 29-06-2022 30-06-2022 Closed NA
50 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)
 Vaksin Vaksin Moderna 18-05-2022 19-05-2022 Closed NA
51 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)
 Vaksin Inavac 24-03-2022 25-03-2022 Closed NA
52 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
 Vaksin Vaksin SARS-COV-2 (Vero Cell) Sinopharm 14-03-2022 15-03-2022 Closed NA
53 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)
 Vaksin Vaksin Inavac 02-02-2022 03-02-2022 Closed NA
54 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
 Vaksin Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) 20-01-2022 26-01-2022 Closed NA
55 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)
 Vaksin Vaksin AstraZeneca, Pfizer, Sinovac 23-12-2021 24-12-2021 Closed NA
56 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
 Vaksin Vaksin AdimrSc-2f 13-12-2021 14-12-2021 Closed NA
57 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
 Vaksin Vaksin Sf9 08-12-2021 10-12-2021 Closed NA
58 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
 Vaksin Vaksin ARCoV 03-12-2021 07-12-2021 Closed NA
59 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)
 Vaksin SARS-CoV-2 Protein Subunit Recombinant Vaccine 26-11-2021 27-11-2021 Closed NA
60 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
 Obat Colchicine, Dexamethasone, Empaglifozine 08-11-2021 10-11-2021 Closed NA
61 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)
 Obat Remdesivir 11-10-2021 15-10-2021 Closed NA
62 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
 Produk Biologi UCMSC 20-09-2021 24-09-2021 Closed NA
63 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
 Obat Ivermectin 13-09-2021 17-09-2021 Closed NA
64 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)
 Produk Biologi Plasma Konvalesen 12-08-2021 20-08-2021 Closed NA
65 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
 Produk Biologi Plasma Konvalesen 12-08-2021 20-08-2021 Closed NA
66 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
 Vaksin Zifivax 17-06-2021 18-06-2021 Closed NA
67 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
 Produk Biologi Plasma Konvalesen 15-06-2021 16-06-2021 Closed NA
68 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
 Vaksin Vaksin Zifivax 25-03-2021 26-03-2021 Closed NA
69 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
 Produk Biologi Sel Dendritik Autolog 12-03-2021 13-03-2021 Closed Peringatan
70 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
 Obat Favipiravir 17-12-2020 18-12-2020 Closed NA
71 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
 Produk Biologi Sel dendritik 14-12-2020 15-12-2020 Closed
72 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)
 Produk Biologi Sel punca mesenkimal 12-10-2020 27-10-2020 Closed
73 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)
 Produk Biologi Sel punca mesenkimal 22-09-2020 02-10-2020
74 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.
Obat BDB-001 20-09-2020 25-09-2020 Closed
75 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
 Vaksin Vaksin COVID-19 08-09-2020 09-09-2020 Closed NA
76 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.
Obat 07-09-2020 15-09-2020 Closed
77 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
 Obat Favipiravir 19-08-2020 25-08-2020
78 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.
 Obat Kombinasi Lopinavir/Ritonavir 27-07-2020 28-07-2020 Closed
79 Pharmacodynamic Equivalence Of Ovine Enoxaparin To Porcine Enoxaparin (lovenox®) In Healthy Volunteers PT. Metiska Farma
PT. Pharma Metric Labs, Jakarta
Prof. Arini Setiawati, PhD
Obat Enoxaparin 10-02-2020 11-02-2020 Closed
80 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.
Vaksin Vaksin Hepatitis B 10-02-2020 11-02-2020 Closed NA
81 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
Obat Netupitant 16-12-2019 17-12-2019 Closed NA
82 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
 Vaksin Hepatitis B Vaccine 28-10-2019 30-10-2019 Closed NA
83 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)
 Obat Inaplant 08-10-2019 09-10-2019 Closed NA
84 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
 Obat Dexamethasone 22-07-2019 23-07-2019 Closed NA
85 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)
 Obat Deferiprone 16-07-2019 17-07-2019 Closed NA
86 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)
 Obat TRUNCATE-TB 09-07-2019 10-07-2019 Closed NA
87 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)
 Obat TRUNCATE-TB 29-04-2019 30-04-2019 Closed NA
88 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
 Vaksin Vi-DT Typhoid Conjugate Vaccine 13-03-2019 14-03-2019 Closed NA
Last Updated on : 10-09-2025 09:39