RecruitingPhase 3NCT07200908

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

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

Sponsor

Mirum Pharmaceuticals, Inc.

Enrollment

172 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis D Infection

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Brelovitug 300 mg and a drug called Bulevirtide 2 mg and Brelovitug - 300 mg for people with chronic hepatitis d infection. The study is currently recruiting participants at 48 locations. People eligible for this study include aged 18 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrelovitug 300 mg

Route of administration- Subcutaneous Injection

DRUGBulevirtide 2 mg and Brelovitug - 300 mg

Route of Administration- Subcutaneous Injection

Locations(48)

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

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

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

AOU Pisana - Cisanello

Pisa, Italy

National Institute of Infectious Diseases Lazzaro Spallanzani

Roma, Italy

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

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

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