A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

NCT07200908 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: BJT-778-3022024-517167-23-00
• Study Type: interventional
• Target: 172
• Locations: 10 countries
• Sites: 44

Brief Summary

This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.

Conditions

Chronic Hepatitis D Infection

Keywords

Hepatitis Delta virus, HDV, Hepatitis D infection; Hepatitis D virus

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with a composite endpoint of virologic response and ALT normalization

  The composite endpoint is defined as virologic response (undetectable HDV RNA, \< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])

  Week 48

Secondary Outcomes (17)

• Percentage of participants with treatment-emergent adverse events (TEAEs)

  Up to 96 weeks

• Percentage of participants who discontinue treatment due to an adverse event (AE)

  Up to 96 weeks

• Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND

  Up 96 Weeks

• Percentage of participants with HDV RNA <LLOQ

  Up to 96 Weeks

• Percentage of participants with HDV RNA <LLOQ, TND

  Up to 96 Weeks

Study Arms (2)

Brelovitug

EXPERIMENTAL

Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks

Drug: Brelovitug 300 mg

Bulevirtide for 48 weeks followed by brelovitug for 48 weeks

ACTIVE COMPARATOR

Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.

Drug: Bulevirtide 2 mg and Brelovitug - 300 mg

Interventions

Brelovitug 300 mg DRUG

Route of administration- Subcutaneous Injection

Also known as: BJT-778, BTG

Brelovitug

Bulevirtide 2 mg and Brelovitug - 300 mg DRUG

Route of Administration- Subcutaneous Injection

Also known as: Hepcludex

Bulevirtide for 48 weeks followed by brelovitug for 48 weeks

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Chronic HDV infection
• HDV RNA \>500 IU/mL at Screening
• ALT \>ULN at Screening
• Willing to take or already taking HBV neucleos(t)ide therapy.

You may not qualify if:

• Pregnant or nursing females
• Unwilling to comply with contraception requirements during the study
• Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
• Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
• Solid organ or bone marrow transplantation
• Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.

Sponsors & Collaborators

• Mirum Pharmaceuticals, Inc.: lead

Study Sites (44)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

Universitätsklinikum St. Pölten

Sankt Pölten, 3100, Austria

RECRUITING

Fakultni Nemocnice Brno

Brno, Brno, 62500, Czechia

RECRUITING

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Hradec Králové, 500 03, Czechia

RECRUITING

Krajská nemocnice Liberec, a.s.

Liberec, Liberec, 460 01, Czechia

RECRUITING

Institute For Clinical And Experimental Medicine

Prague, Prague, 140 00, Czechia

RECRUITING

Klin Med s.r.o.

Prague, Prague, 2 120 00, Czechia

RECRUITING

Hôpital Estaing

Clermont-Ferrand, 63000, France

RECRUITING

Hôpital Beaujon

Clichy, 92110, France

RECRUITING

University Hospital Henri Mondor - APHP

Créteil, 94000, France

RECRUITING

CHU Grenoble Alpes Hopital Nord Michallon

La Tronche, 38700, France

RECRUITING

Site 512 Centre Hospitalier de Versailles _ Hopital Andre Magnot

Le Chesnay, 78157, France

NOT YET RECRUITING

University Hospital Limoges

Limoges, 87042, France

RECRUITING

Hôpital de la Croix-Rousse

Lyon, 69004, France

RECRUITING

Hôpital Pitié Salpêtrière

Paris, 75013, France

NOT YET RECRUITING

Centre Hospitalier Universitaire De Rennes

Rennes, 35000, France

RECRUITING

Hôpital Rangueil

Toulouse, 31059, France

RECRUITING

Goethe University Frankfurt

Frankfurt, Frankfurt, 60590, Germany

RECRUITING

Rostock University Medical Center

Rostock, Rostock, 18057, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

National Institute Of Infectious Diseases

Bucharest, Bucharest, 021105, Romania

RECRUITING

Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes

Bucharest, Bucharest, 030303, Romania

RECRUITING

Centrul Medical Unirea S.R.L

Iași, Lasi, 700023, Romania

RECRUITING

National Institute of Infectious Diseases Prof Dr Matei Bals

Bucharest, 021105, Romania

RECRUITING

Spitalul Clinic de Boli Infectioase Constanta

Constanța, 900709, Romania

RECRUITING

Hospital Universitario Torrecardenas

Almería, Almeria, 04009, Spain

RECRUITING

Hospital Universitari Vall D Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Clinic Provincial De Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

RECRUITING

Hospital Universitario Álvaro Cunqueiro

Vigo, 36312, Spain

RECRUITING

Karolinska University Hospital

Huddinge, 14186, Sweden

RECRUITING

Hôpitaux Universitaires

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

HOCH Health Ostschweiz

Sankt Gallen, St.Gallen, 95 9007, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

Queen Elizabeth Hospital Birmingham

Birmingham, Birmingham, B15 2GW, United Kingdom

RECRUITING

Chelsea and Westminster Hospital NHS Foundation Trust

London, London, SW10 9NH, United Kingdom

RECRUITING

North Manchester General Hospital

Manchester, Manchester, M8 5RB, United Kingdom

RECRUITING

Hull University Teaching Hospitals

Cottingham, HU16 5JQ, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E12ES, United Kingdom

RECRUITING

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hepatitis D

Interventions

bulevirtide

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Clinical Trials Clinical Trials Mirum

CONTACT

+16506674085; clinicaltrials@mirumpharma.com

Mirum Pharmaceuticals, Inc., Clinical Trials

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (5); AU (2); IT (1); FR (10); ES (7); DE (4); SE (1); CH (3); GB (6); CZ (5)