7 completed, 6 recruiting, 3 active not recruiting, 1 approved for marketing. 4 Phase 2, 4 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 2, Active not recruiting 1, Recruiting 1 |
| Phase 3 | 4 | Recruiting 2, Active not recruiting 1, Completed 1 |
| Phase 1 | 2 | Completed 2 |
Follow bulevirtide: new trials by email Literature Review of bulevirtide trials Research Report on bulevirtide
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 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 |
| Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D Bulevirtide, No intervention - HEPATITIS B CHRONIC, Hepatitis D | Recruiting | Research Center of Periodontal-Systemic Interactions | 25 | 2026-02-15 | 2026-03-25 | |
| 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 Versus Bulevirtide in Chronic HDV Infection Tobevibart, Elebsiran, Bulevirtide - Viral Hepatitis | Phase 2 | Active not recruiting | Vir Biotechnology, Inc. | 100 | 2025-08-05 | 2026-01-16 |
| 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 |
| Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment Bulevirtide - Hepatitis D | Completed | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | 192 | 2024-09-01 | 2026-11-05 | |
| Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis Bulevirtide - Hepatitis D | Recruiting | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | 266 | 2024-05-06 | 2026-11-06 | |
| Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients Bulevirtide - Chronic Hepatitis D | Recruiting | Karolinska University Hospital | 400 | 2023-09-27 | 2023-09-29 | |
| HEllenic Multicenter ReAl-life CLInical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV Bulevirtide - Hepatitis D | Unknown | University of Athens | 80 | 2023-05-01 | 2023-07-03 | |
| Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD) Bulevirtide - Hepatitis D | Recruiting | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | 100 | 2023-05-01 | 2026-11-05 | |
| Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy Bulevirtide - Hepatitis D | Completed | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | 50 | 2023-04-01 | 2023-07-27 | |
| Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function Bulevirtide - Hepatic Impairment, Healthy | Phase 1 | Completed | Gilead Sciences | 74 | 2023-03-15 | 2026-01-26 |
| A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function Bulevirtide (BLV) - Chronic Hepatitis D Infection | Phase 1 | Completed | Gilead Sciences | 41 | 2023-03-15 | 2025-09-18 |
| Study of Bulevirtide in Participants With Chronic Hepatitis D Infection Bulevirtide - Chronic Hepatitis D Infection | Terminated | Gilead Sciences | 170 | 2023-02-07 | 2026-09-18 | |
| Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D) Bulevirtide - Hepatitis D, Hepatitis B | Active not recruiting | Hannover Medical School | 11 | 2021-05-07 | 2025-09-15 | |
| Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD) Bulevirtide, Peginterferon Alfa-2a (PEG-IFN alfa) - Chronic Hepatitis Delta | Phase 2 | Completed | Gilead Sciences | 175 | 2019-05-31 | 2024-10-08 |
| 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 |
| Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent Myrcludex B, PEG IFN alfa-2a, Tenofovir - Chronic Viral Hepatitis B With Delta-agent | Phase 2 | Completed | Hepatera Ltd. | 90 | 2016-04-01 | 2021-04-30 |
| Expanded Access for Bulevirtide Bulevirtide - Chronic Hepatitis Delta Virus Infection | Approved for marketing | Gilead Sciences | 2026-06-12 |
Hepatitis D (10) · Hepatitis D, Chronic (6) · Digestive System Diseases (2) · Hepatitis (2) · Liver Diseases (2) · Hepatitis B (1) · Hepatitis B, Chronic (1) · Hypertension, Portal (1) · Liver Cirrhosis (1) · Periodontitis (1)
Gilead Sciences (6) · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (4) · Mirum Pharmaceuticals, Inc. (2) · Vir Biotechnology, Inc. (2) · Hannover Medical School (1) · Hepatera Ltd. (1) · Karolinska University Hospital (1) · Research Center of Periodontal-Systemic Interactions (1) · University of Athens (1)
Italy (8) · Germany (7) · Romania (7) · France (6) · Spain (5) · United Kingdom (5) · Austria (4) · Russia (3) · Sweden (3) · United States (3) · Czechia (2) · Moldova (2) · Pakistan (2) · Belgium (1) · Bulgaria (1)
Benjamin Maasoumy, MD (1) · Pavel Bogomolov, PhD (1)
PMID 39648559, PMID 38340811, PMID 41586499, PMID 27132170, PMID 32684365, PMID 33895531, PMID 34155795, PMID 37120031, PMID 37288712, PMID 37345876, PMID 38842520, PMID 39009085, PMID 39853842, PMID 40736690, PMID 41405233, PMID 41674894, PMID 41966308
2019 (2)