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RECRUITING
NCT07454837
PHASE2/PHASE3

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

Sponsor: Mirum Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-02-26

Completion Date

2029-03-30

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DRUG

Brelovitug (BJT-778)

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

DRUG

Bulevirtide

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