Bulevirtide

DRUG18 trials

Sponsors

Bluejay Therapeutics Inc., Gilead Sciences, Hannover Medical School, University of Athens, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Conditions

Chronic Hepatitis DChronic Hepatitis D InfectionChronic Hepatitis DeltaChronic Hepatitis Delta Virus InfectionHEPATITIS B CHRONICHealthyHepatic ImpairmentHepatitis B

Phase 1

Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function

CompletedNCT05765344

Gilead SciencesHealthy, Hepatic Impairment

Start: 2023-03-15End: 2025-01-13Updated: 2026-01-26

Phase 2

Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)

CompletedNCT03852433

Gilead SciencesChronic Hepatitis Delta

Start: 2019-05-31End: 2022-09-28Updated: 2024-10-08

A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection

Active, not recruitingNCT07142811

Vir Biotechnology, Inc.Viral Hepatitis

Start: 2025-08-05End: 2030-07-01Target: 100Updated: 2026-01-16

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

Not yet recruitingCTIS2025-522015-42-00

Bluejay Therapeutics Inc.Chronic Hepatitis D Infection

Target: 55Updated: 2026-02-05

Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

RecruitingNCT07454837

Mirum Pharmaceuticals, Inc.Chronic Hepatitis D

Start: 2026-02-26End: 2029-03-30Target: 120Updated: 2026-09-10

Phase 3

Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)

CompletedNCT03852719

Gilead SciencesChronic Hepatitis Delta

Start: 2019-04-17End: 2024-08-08Updated: 2025-08-22

A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

RecruitingCTIS2024-517167-23-00

Bluejay Therapeutics Inc.Chronic Hepatitis D Infection

Start: 2025-08-28Target: 141Updated: 2026-01-16

A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide

Active, not recruitingNCT07128550

Vir Biotechnology, Inc.Viral Hepatitis

Start: 2025-07-30End: 2031-07-01Target: 150Updated: 2026-07-13

Unknown Phase

Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)

Active, not recruitingNCT04863703

Hannover Medical SchoolHepatitis B, Hepatitis D, Liver Cirrhosis +1

Start: 2021-05-07End: 2026-12-31Target: 11Updated: 2025-09-15

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Active, not recruitingNCT05718700

Gilead SciencesChronic Hepatitis D Infection

Start: 2023-02-07End: 2028-07-31Updated: 2025-11-17

HEllenic Multicenter ReAl-life CLInical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV

University of AthensHepatitis D

Start: 2023-05-01End: 2023-12-30Target: 80Updated: 2023-07-03

Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy

CompletedNCT05962307

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoHepatitis D

Start: 2023-04-01End: 2023-05-31Updated: 2023-07-27

Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients

RecruitingNCT06051045

Karolinska University HospitalChronic Hepatitis D

Start: 2023-09-27End: 2033-03-31Target: 400Updated: 2023-09-29

Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)

RecruitingNCT06122285

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoHepatitis D

Start: 2023-05-01End: 2025-12-31Target: 100Updated: 2025-01-10

Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

RecruitingNCT06397859

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoHepatitis D

Start: 2024-05-06End: 2026-08-31Target: 266Updated: 2024-06-17

Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment

RecruitingNCT06504485

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoHepatitis D

Start: 2024-09-01End: 2026-02-28Target: 192Updated: 2026-01-15

Expanded Access for Bulevirtide

Gilead SciencesChronic Hepatitis Delta Virus Infection

Updated: 2026-06-12

Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D

RecruitingNCT07491848

Research Center of Periodontal-Systemic InteractionsHEPATITIS B CHRONIC, Hepatitis D, Periodontitis

Start: 2026-02-15End: 2027-02-15Target: 25Updated: 2026-03-25

Related Papers

HERACLIS_BLV_D: Adherence to Real‐Life Therapy With Bulevirtide in Chronic Hepatitis D

Journal of Viral Hepatitis2026-06-19

Impact of Double Reflex Testing and Linkage to Treatment on Clinical Outcomes of Chronic Hepatitis Delta Virus Infection in the United States.

2026-01-01

P-2195. Influence of Nucleos(t)ide Analogue Use with Bulevirtide on Treatment Outcomes in Chronic Hepatitis Delta

Open Forum Infectious Diseases2026-01-01

P-2191. Efficacy and safety of buleviritide monotherapy for chronic hepatitis D in patients with and without cirrhosis: results from the week 144 interim analysis of a phase 3 randomized study

Open Forum Infectious Diseases2025-01-29

Phase 2 Randomised Study of Bulevirtide as Monotherapy or Combined With Peg‐<scp>IFNα</scp>‐2a as Treatment for Chronic Hepatitis Delta

Liver International2025-01-248 citations

Bulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48

Liver International2024-12-0810 citations

Patient-reported outcomes in chronic hepatitis delta: An exploratory analysis of the phase III MYR301 trial of bulevirtide.

2024-07-1413 citations

Bulevirtide Combined with Pegylated Interferon for Chronic Hepatitis D

New England Journal of Medicine2024-06-0658 citations

Bulevirtide monotherapy in patients with chronic HDV: Efficacy and safety results through week 96 from a phase III randomized trial.

2024-05-0936 citations

Blocking viral entry with bulevirtide reduces the number of HDV-infected hepatocytes in human liver biopsies

Journal of Hepatology2024-02-0833 citations

Efficacy and Safety at 96 weeks of Bulevirtide 2 mg or 10 mg Monotherapy for Chronic Hepatitis Delta: Results From an Interim Analysis of a Phase 3 Randomized Study

Zeitschrift für Gastroenterologie2024-01-011 citations

P132 Continued treatment of early nonresponder or partial virologic responders with bulevirtide monotherapy in patients with chronic hepatitis delta (CHD) through week 96 leads to improvement in virologic and biochemical responses

Poster presentations2023-09-011 citations

P134 Efficacy and safety at 96 weeks of bulevirtide 2 mg or 10 mg monotherapy for chronic hepatitis delta: results from an interim analysis of a phase 3 randomized study

Poster presentations2023-09-01

Efficacy and safety of bulevirtide monotherapy given at 2-mg or 10-mg dose level once daily for treatment of chronic hepatitis delta: Week 48 primary endpoint results from a Phase 3 randomized, multicenter, parallel design study

Zeitschrift für Gastroenterologie2023-08-011 citations

A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D

New England Journal of Medicine2023-06-22186 citations

No virologic resistance to bulevirtide monotherapy detected in patients through 24 weeks treatment in phase II and III clinical trials for chronic hepatitis delta.

2023-04-2717 citations

Efficacy and Safety of Bulevirtide Monotherapy Given at 2 mg or 10 mg Dose Level Once Daily for Treatment of Chronic Hepatitis Delta: Week 48 Primary Endpoint Results from a Phase 3 Randomized, Multicenter, Parallel Design Study

Zeitschrift für Gastroenterologie2023-01-011 citations