RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Mirum Pharmaceuticals, Inc. • ClinicalTrials.gov ID: NCT07200908

Registry updated: 2026-10-08

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Description

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.

Interventions

Brelovitug 300 mg (Drug)
Route of administration- Subcutaneous Injection
Bulevirtide 2 mg and Brelovitug - 300 mg (Drug)
Route of Administration- Subcutaneous Injection

Eligibility criteria

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV neucleos(t)ide therapy. Key Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to comply with contraception requirements during the study 3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). 5. Solid organ or bone marrow transplantation 6. Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma. Note - Other protocol-defined Inclusion/Exclusion criteria apply.

Conditions

Chronic Hepatitis D Infection

Locations

Medical University of Graz — Graz, Austria
Universitätsklinikum St. Pölten — Sankt Pölten, Austria
Fakultni Nemocnice Brno — Brno, Brno, Czechia
Fakultni Nemocnice Hradec Kralove — Hradec Králové, Hradec Králové, Czechia
Krajská nemocnice Liberec, a.s. — Liberec, Liberec, Czechia
Institute For Clinical And Experimental Medicine — Prague, Prague, Czechia
Klin Med s.r.o. — Prague, Prague, Czechia
Hôpital Estaing — Clermont-Ferrand, France
Hôpital Beaujon — Clichy, France
University Hospital Henri Mondor - APHP — Créteil, France
CHU Grenoble Alpes Hopital Nord Michallon — La Tronche, France
Centre Hospitalier de Versailles _ Hopital Andre Magnot — Le Chesnay, France
Lille Regional University Hospital Centre — Lille, France
University Hospital Limoges — Limoges, France
Hôpital de la Croix-Rousse — Lyon, France
Hôpital Pitié Salpêtrière — Paris, France
Hopital Cochin — Paris, France
CHU de Bordeaux - Hopital Haut-Leveque — Pessac, France
Centre Hospitalier Universitaire De Rennes — Rennes, France
Hôpital Rangueil — Toulouse, France
Goethe University Frankfurt — Frankfurt, Frankfurt, Germany
Rostock University Medical Center — Rostock, Rostock, Germany
Universitätsklinikum Düsseldorf — Düsseldorf, Germany
Medizinische Hochschule Hannover — Hanover, Germany
ASST Papa Giovanni XXIII — Bergamo, Italy
Humanitas Research Hospital — Milan, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
University of Parma — Parma, Italy
AOU Pisana - Cisanello — Pisa, Italy
National Institute of Infectious Diseases Lazzaro Spallanzani — Roma, Italy
Aga Khan University, Aga Khan Hospital and Medical College Foundation — Karachi, Pakistan
National Institute Of Infectious Diseases — Bucharest, Bucharest, Romania
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes — Bucharest, Bucharest, Romania
Centrul Medical Unirea S.R.L — Iași, Lasi, Romania
National Institute of Infectious Diseases Prof Dr Matei Bals — Bucharest, Romania
Fundeni Clinical Institute — Bucharest, Romania
Spitalul Clinic de Boli Infectioase Constanta — Constanța, Romania
Hospital Universitario Torrecardenas — Almería, Almeria, Spain
Hospital Universitari Vall D Hebron — Barcelona, Barcelona, Spain
Hospital Clinic Provincial De Barcelona — Barcelona, Spain
Hospital Universitario Ramón y Cajal — Madrid, Spain
Hospital Universitario Virgen de la Victoria — Málaga, Spain
Hospital Universitario Marqués de Valdecilla — Santander, Spain
Hospital Universitario Álvaro Cunqueiro — Vigo, Spain
Karolinska University Hospital — Huddinge, Sweden
Hôpitaux Universitaires — Geneva, Canton of Geneva, Switzerland
HOCH Health Ostschweiz — Sankt Gallen, St.Gallen, Switzerland
Universitätsspital Zürich — Zurich, Switzerland
Queen Elizabeth Hospital Birmingham — Birmingham, Birmingham, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust — London, London, United Kingdom
North Manchester General Hospital — Manchester, Manchester, United Kingdom
Hull University Teaching Hospitals — Cottingham, United Kingdom
Barts Health NHS Trust — London, United Kingdom
King's College Hospital NHS Foundation Trust — London, United Kingdom
Republican Specialized Scientific and Practical Medical Center of Epidemiology, Microbiology, Infectious and Parasitic Diseases — Fergana, Uzbekistan
Research Institute of Virology of the Republic of Uzbekistan — Tashkent, Uzbekistan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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