196 completed, 22 unknown, 20 terminated, 7 active not recruiting. 261 Phase 3, 17 Phase 2.
Follow Hepatitis B: new trials by email Literature Review of Hepatitis B trials Research Report on Hepatitis B
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of BK1803 in Healthy Infants BK1803, GOBIK Aqueous Suspension Syringes, Bimmugen® Injection - Pertussis, Diphtheria | Phase 3 | Recruiting | Tanabe Pharma Corporation | 344 | 2026-10-21 | 2026-11-12 |
| Study Interchangeability Hep-B Vaccine Administered at Birth Dose In-house Hepatitis B Vaccine, Registered Hepatitis B Vaccine - Vaccination Adverse Event, Immunogenicity, Vaccine | Phase 3 | Not yet recruiting | PT Bio Farma | 270 | 2026-10-01 | 2026-10-02 |
| Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response TQA3605 tablets Placebo, TQA3605 tablets, Entecavir dispersible tablets - Chronic Hepatitis B | Phase 3 | Not yet recruiting | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 930 | 2026-09-01 | 2026-10-02 |
| Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP, 3P mHealth package - HIV Infection, Sexually Transmitted Infection | Phase 3 | Not yet recruiting | HIV Prevention Trials Network | 400 | 2026-09-01 | 2026-06-22 |
| Phase IIIB Extension Clinical Trial of Efficacy and Safety of GST-HG141 (Nairevir) Combined With NAs in Chronic Hepatitis B GST-HG141 - Chronic Hepatitis b | Phase 3 | Not yet recruiting | Fujian Akeylink Biotechnology Co., Ltd. | 576 | 2026-06-26 | 2026-05-14 |
| Optimal Timing of Hepatitis B Vaccination After Transplants hepatitis B vaccine - Transplant-Related Disorder, Hepatitis b Virus Infection | Phase 3 | Withdrawn | Institute of Hematology & Blood Diseases Hospital, China | 2026-01-01 | 2026-11-12 | |
| Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) Recombinant Hepatitis B new Bulk vaccine, DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine, Recombinant Hepatitis B vaccine (Registered BioFarma) - Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction | Phase 3 | Withdrawn | PT Bio Farma | 2025-12-01 | 2025-06-05 | |
| Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III) In-House Recombinant Hepatitis B (Bio Farma) vaccine, Registered Hepatitis B vaccine recombinant (Engerix-B) - Vaccine Reaction, Vaccine Adverse Reaction | Phase 3 | Not yet recruiting | PT Bio Farma | 540 | 2025-09-01 | 2025-06-06 |
| A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B AZVUDINE, TAF, IFNα-2a - Chronic Hepatitis B, Azvudine | Phase 3 | Recruiting | Zhigang Ren | 120 | 2025-09-01 | 2025-12-29 |
| Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) AHB-137, Placebo, NA therapy - Chronic Hepatitis B | Phase 3 | Active not recruiting | Ausper Biopharma Co., Ltd. | 577 | 2025-08-12 | 2026-05-04 |
| A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB ZM-H1505R 100mg, ZM-H1505R Placebo, NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments - Chronic Hepatitis B | Phase 3 | Not yet recruiting | Shanghai Zhimeng Biopharma, Inc. | 1300 | 2025-08-01 | 2025-08-03 |
| To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment GST-HG141, GST-HG141 Placebo - Chronic Hepatitis b | Phase 3 | Recruiting | Fujian Akeylink Biotechnology Co., Ltd. | 526 | 2025-07-24 | 2026-01-23 |
| A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B HTS 20mg, HTS 30mg, HTS 40mg - Chronic Hepatitis B | Phase 2 / Phase 3 | Active not recruiting | Xi'an Xintong Pharmaceutical Research Co.,Ltd. | 1444 | 2025-07-01 | 2025-10-02 |
| A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series LBVD, Pentavalent vaccine and Inactivated Polio vaccine - Diphtheria, Tetanus | Phase 2 / Phase 3 | Active not recruiting | LG Chem | 1186 | 2025-05-30 | 2026-09-03 |
| Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes Obeticholic Acid 5 mg - Hepatitis B Virus, Steatosis | Phase 3 | Not yet recruiting | Assiut University | 100 | 2024-11-15 | 2024-11-15 |
| A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. Undiluted I.V.-Hepabig inj(GC5103), Diluted I.V.-Hepabig inj(GC5103) - Hepatitis B | Phase 3 | Recruiting | GC Biopharma Corp | 105 | 2023-04-13 | 2025-06-25 |
| Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) Bepirovirsen, Placebo - Chronic Hepatitis B, Hepatitis B, Chronic | Phase 3 | Completed | GlaxoSmithKline | 981 | 2022-12-07 | 2026-07-08 |
| Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2) Bepirovirsen, Placebo - Chronic Hepatitis B, Hepatitis B, Chronic | Phase 3 | Completed | GlaxoSmithKline | 857 | 2022-12-06 | 2026-07-08 |
| Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection Peginterferon Alfacon-2, Peginterferon Alfacon-2 placebo - Chronic Hepatitis B Virus Infection | Phase 3 | Completed | Beijing Kawin Technology Share-Holding Co., Ltd. | 336 | 2021-12-28 | 2024-08-09 |
| Reducing Vertical Transmission of Hepatitis B in Africa Tenofovir Disoproxil Fumarate, Lamivudine Oral Solution - Hepatitis B Infection | Phase 3 | Active not recruiting | University of Alabama at Birmingham | 334 | 2021-09-03 | 2026-08-24 |
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Hepatitis B, Chronic (85) · Diphtheria (57) · Tetanus (56) · Haemophilus Infections (47) · Whooping Cough (43) · Poliomyelitis (37) · HIV Infections (10) · Hepatitis (9) · Hepatitis A (8) · Virus Diseases (7) · Liver Diseases (5) · Acquired Immunodeficiency Syndrome (4) · Bacterial Infections (4) · Hepatitis C (4)
Blood-Borne Infections (261) · DNA Virus Infections (261) · Digestive System Diseases (261) · Hepadnaviridae Infections (261) · Infections (261) · Communicable Diseases (260) · Hepatitis, Viral, Human (259) · Liver Diseases (256) · Virus Diseases (254) · Hepatitis (252) · Pathological Conditions, Signs and Symptoms (100) · Pathologic Processes (99) · Disease Attributes (97) · Chronic Disease (91) · Hepatitis, Chronic (85)
Tenofovir (30) · Hepatitis B Vaccines (24) · entecavir (24) · Engerix-B (21) · peginterferon alfa-2a (18) · Lamivudine (14) · Telbivudine (14) · adefovir dipivoxil (14) · diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine (13) · DTaP-IPV-HB-PRP-T vaccine (9) · adefovir (9) · clevudine (8) · peginterferon alfa-2b (7) · Hiberix (6) · Heptavalent Pneumococcal Conjugate Vaccine (5)
GlaxoSmithKline (60) · Sanofi Pasteur, a Sanofi Company (23) · Merck Sharp & Dohme LLC (17) · Bristol-Myers Squibb (13) · Gilead Sciences (8) · Hoffmann-La Roche (6) · Novartis (6) · Novartis Pharmaceuticals (6) · Dynavax Technologies Corporation (5) · Henogen (5) · Bukwang Pharmaceutical (4) · VBI Vaccines Inc. (4) · Crucell Holland BV (3) · French National Agency for Research on AIDS and Viral Hepatitis (3) · MCM Vaccines B.V. (3)
United States (51) · China (33) · South Korea (33) · Canada (30) · Thailand (26) · Spain (24) · Germany (23) · Italy (22) · Taiwan (22) · Belgium (21) · France (21) · Australia (19) · United Kingdom (19) · Poland (18) · Turkey (Türkiye) (18)
Averell Sherker, MD (3) · Christian Tielemans, MD, PhD (3) · Hyo-Suk Lee, MD. PhD (3) · Anna Lok, MD (2) · Fabrice Carrat, MD (2) · Francisco Diaz-Mitoma, MD, PhD (2) · Gonzague Jourdain, MD, PhD (2) · John Flaherty, PharmD (2)
PMID 17716936, PMID 19052126, PMID 20955704, PMID 23234725, PMID 23364953, PMID 23939953, PMID 25179493, PMID 25277773, PMID 25532501, PMID 25788199, PMID 25987775, PMID 27658343, PMID 28215615, PMID 30795958, PMID 31136052, PMID 42206582, PMID 16525137, PMID 16525138, PMID 17090650, PMID 17647293, PMID 17909201, PMID 18080339, PMID 18094378, PMID 19345439, PMID 20028815, PMID 20523113, PMID 20724955, PMID 20936979, PMID 20949113, PMID 20950456, PMID 21289531, PMID 21334243, PMID 21552183, PMID 21875633, PMID 21892006, PMID 22075088, PMID 22157567, PMID 22170543, PMID 22185811, PMID 22349525, PMID 22531237, PMID 22544804, PMID 22643350, PMID 22691430, PMID 22789511, PMID 22859496, PMID 22913681, PMID 23152368, PMID 23234302, PMID 23727002
U01DK082843 (3), U01DK082864 (3), U01DK082871 (3), U01DK082874 (3), U01DK082944 (3), UL1TR000004 (3), 2004 (2), 2008 (2), 2009 (2), 2016 (2), 2017 (2), M01RR000040 (2), P01HL009011 (2), P30DK050306 (2), U01DK082863 (2)