A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
Universitätsklinikum St. Pölten
RECRUITING
Sankt Pölten
France
Hôpital Estaing
RECRUITING
Clermont-ferrand
Hôpital Beaujon
RECRUITING
Clichy
University Hospital Henri Mondor - APHP
RECRUITING
Créteil
CHU Grenoble Alpes Hopital Nord Michallon
RECRUITING
La Tronche
Site 512 Centre Hospitalier de Versailles _ Hopital Andre Magnot
NOT_YET_RECRUITING
Le Chesnay
University Hospital Limoges
RECRUITING
Limoges
Hôpital de la Croix-Rousse
RECRUITING
Lyon
Hôpital Pitié Salpêtrière
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire De Rennes
RECRUITING
Rennes
Hôpital Rangueil
RECRUITING
Toulouse
Germany
Universitätsklinikum Düsseldorf
RECRUITING
Düsseldorf
Goethe University Frankfurt
RECRUITING
Frankfurt
Medizinische Hochschule Hannover
RECRUITING
Hanover
Rostock University Medical Center
RECRUITING
Rostock
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Romania
National Institute Of Infectious Diseases
RECRUITING
Bucharest
National Institute of Infectious Diseases Prof Dr Matei Bals
RECRUITING
Bucharest
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
RECRUITING
Bucharest
Spitalul Clinic de Boli Infectioase Constanta
RECRUITING
Constanța
Centrul Medical Unirea S.R.L
RECRUITING
Iași
Spain
Hospital Universitario Torrecardenas
RECRUITING
Almería
Hospital Clinic Provincial De Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall D Hebron
RECRUITING
Barcelona
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Álvaro Cunqueiro
RECRUITING
Vigo
Sweden
Karolinska University Hospital
RECRUITING
Huddinge
Switzerland
Hôpitaux Universitaires
RECRUITING
Geneva
HOCH Health Ostschweiz
RECRUITING
Sankt Gallen
Universitätsspital Zürich
RECRUITING
Zurich
United Kingdom
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Hull University Teaching Hospitals
RECRUITING
Cottingham
Barts Health NHS Trust
RECRUITING
London
Chelsea and Westminster Hospital NHS Foundation Trust
RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
North Manchester General Hospital
RECRUITING
Manchester
Contact Information
Primary
Clinical Trials Clinical Trials Mirum
clinicaltrials@mirumpharma.com
+16506674085
Backup
Mirum Pharmaceuticals, Inc., Clinical Trials
Time Frame
Start Date: 2025-08-27
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 172
Treatments
Experimental: Brelovitug
Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Active_comparator: Bulevirtide for 48 weeks followed by brelovitug for 48 weeks
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.
Related Therapeutic Areas
Sponsors
Leads: Mirum Pharmaceuticals, Inc.