RecruitingPhase 2Phase 3NCT07454837

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

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)

Sponsor

Mirum Pharmaceuticals, Inc.

Enrollment

120 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis D

Summary

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Brelovitug (BJT-778) and a drug called Bulevirtide for people with chronic hepatitis d. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 18 Years and older.

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 (BJT-778)

Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.

DRUGBulevirtide

Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.

Locations(22)

Medical University of Graz

Graz, Austria

Fakultni Nemocnice Brno (University Hospital Brno)

Brno, Czechia

Klin Med Ltd. (KLIN MED s.r.o.)

Prague, Czechia

Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)

Prague, Czechia

CHU de Bordeaux

Bordeaux, France

Hospital Beaujon

Clichy, France

CHU Toulouse Hospital Rangueil, Toulouse

Toulouse, France

University Hospital of Dusseldorf

Düsseldorf, Germany

Goethe University Frankfurt

Frankfurt, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitatsmedizin Rostock

Rostock, Germany

Centrul Medical Unirea S.R.L

Iași, Lasi, Romania

Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes

Bucharest, Romania

National Institute Of Infectious Diseases Prof. Dr. Matei Bals

Bucharest, Romania

Spitalul Clinic de Boli Infectioase Constanta

Constanța, Romania

Vall d'Hebron Hospital

Barcelona, Spain

Hospital Clinic I Provincial De Barcelona

Barcelona, Spain

Castle Hill Hospital

Cottingham, Yorkshire, United Kingdom

Barts Health NHS Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Chelsea and Westminster Hospital

London, United Kingdom

Manchester University Nhs Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07454837

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