6 completed, 4 active not recruiting, 3 recruiting, 1 not yet recruiting. 15 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 15 | Completed 6, Active not recruiting 4, Recruiting 3, Not yet recruiting 1, Unknown 1 |
| Phase 2 | 2 | Active not recruiting 1, Recruiting 1 |
Follow Hepatitis D: new trials by email Literature Review of Hepatitis D trials Research Report on Hepatitis D
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 |
|---|---|---|---|---|---|---|
| Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D Hepalatide 2.1mg, Placebo of Hepalatide - Hepatitis D, Chronic | Phase 3 | Not yet recruiting | Shanghai HEP Pharmaceutical Co., Ltd. | 150 | 2027-06-01 | 2026-10-28 |
| A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study) Libevitug 20 mg/kg, Libevitug 10 mg/kg, Delayed treatment with libevitug - Chronic Hepatitis D Infection | Phase 3 | Recruiting | Huahui Health | 160 | 2026-04-22 | 2026-08-24 |
| Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide Brelovitug (BJT-778), Bulevirtide - Chronic Hepatitis D | Phase 2 / Phase 3 | Recruiting | Mirum Pharmaceuticals, Inc. | 120 | 2026-02-26 | 2026-10-27 |
| A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg - Chronic Hepatitis D Infection | Phase 3 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 80 | 2026-01-14 | 2026-06-29 |
| A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) Brelovitug 300 mg, Bulevirtide 2 mg and Brelovitug - 300 mg - Chronic Hepatitis D Infection | Phase 3 | Recruiting | Mirum Pharmaceuticals, Inc. | 172 | 2025-08-27 | 2026-10-08 |
| A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide Tobevibart, Elebsiran, Bulevirtide - Viral Hepatitis | Phase 3 | Active not recruiting | Vir Biotechnology, Inc. | 150 | 2025-07-30 | 2026-07-13 |
| A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg - Chronic Hepatitis D Infection | Phase 2 / Phase 3 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 150 | 2025-03-25 | 2026-10-27 |
| A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection Tobevibart, Elebsiran - Viral Hepatitis | Phase 3 | Active not recruiting | Vir Biotechnology, Inc. | 124 | 2025-03-12 | 2026-11-03 |
| Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV Peginterferon Lambda-1a - Hepatitis Delta Virus | Phase 3 | Unknown | Eiger BioPharmaceuticals | 150 | 2021-12-21 | 2023-08-25 |
| Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection Lonafarnib, Ritonavir - Hepatitis D, Chronic | Phase 3 | Completed | Soroka University Medical Center | 10 | 2021-05-15 | 2026-04-30 |
| Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD) Bulevirtide - Chronic Hepatitis Delta | Phase 3 | Completed | Gilead Sciences | 150 | 2019-04-17 | 2025-08-22 |
| Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a Lonafarnib, Ritonavir, PEG IFN-alfa-2a - Hepatitis Delta Virus | Phase 3 | Completed | Eiger BioPharmaceuticals | 407 | 2018-12-01 | 2023-04-14 |
| A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D. peginterferon alfa-2a [Pegasys], placebo, tenofovir - Hepatitis D, Chronic | Phase 3 | Completed | Hoffmann-La Roche | 50 | 2010-02-16 | 2019-01-14 |
| Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603) Peginterferon alfa-2b (PegIntron, SCH 54031) - Hepatitis D, Chronic, Hepatitis B, Chronic | Phase 3 | Completed | Merck Sharp & Dohme LLC | 68 | 2005-12-01 | 2017-04-06 |
| A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD) Pegylated Interferon (PEG-IFN) alfa-2a - Hepatitis D, Chronic | Phase 3 | Completed | Hoffmann-La Roche | 31 | 2005-10-01 | 2016-08-26 |
Hepatitis D, Chronic (9) · Hepatitis (2) · Hepatitis B (2) · Digestive System Diseases (1) · Hepatitis B, Chronic (1) · Liver Diseases (1)
Hepatitis, Viral, Human (15) · Infections (15) · RNA Virus Infections (15) · Virus Diseases (15) · Digestive System Diseases (14) · Liver Diseases (14) · Hepatitis (13) · Chronic Disease (9) · Disease Attributes (9) · Hepatitis, Chronic (9) · Pathologic Processes (9) · Pathological Conditions, Signs and Symptoms (9) · Blood-Borne Infections (2) · Communicable Diseases (2)
bulevirtide (4) · Treatment Delay (3) · peginterferon alfa-2a (3) · Ritonavir (2) · lonafarnib (2) · Tenofovir (1) · myrcludex-B (1) · peginterferon alfa-2b (1) · peginterferon lambda-1a (1)
Mirum Pharmaceuticals, Inc. (4) · Eiger BioPharmaceuticals (2) · Hoffmann-La Roche (2) · Vir Biotechnology, Inc. (2) · Gilead Sciences (1) · Huahui Health (1) · Merck Sharp & Dohme LLC (1) · Shanghai HEP Pharmaceutical Co., Ltd. (1) · Soroka University Medical Center (1)
Germany (7) · Romania (7) · United States (7) · Italy (6) · Pakistan (6) · France (5) · Israel (5) · Spain (5) · Turkey (Türkiye) (5) · United Kingdom (5) · Bulgaria (4) · Georgia (4) · Moldova (4) · New Zealand (4) · Ukraine (4)
Junqi Niu, Professor (1) · Ohad Etzion, MD (1) · Yanhang Gao (1)
PMID 41586499, PMID 30833068, PMID 37120031, PMID 37407002, PMID 38340811, PMID 39009085, PMID 39648559, PMID 39663120, PMID 41405233, PMID 41966308
2019 (1), 2025 (1)