Actively Recruiting
A Global, Randomized, Open-label, Multicenter Trial Evaluating Brelovitug vs Bulevirtide for Chronic Hepatitis Delta Infection
Led by Mirum Pharmaceuticals, Inc. · Updated on 2026-03-27
172
Participants Needed
44
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two treatments, brelovitug (BJT-778) and bulevirtide, for chronic hepatitis delta infection (CHD) in a global Phase 3 study. The main purpose is to compare the effectiveness of brelovitug to bulevirtide as long-term treatments for patients with chronic HDV infection. This open-label, randomized trial involves multiple centers worldwide to assess these therapies' impact on viral response and liver health. The study has two treatment groups. One group receives brelovitug 300 mg by subcutaneous injection once weekly for 96 weeks. The other group receives bulevirtide 2 mg by subcutaneous injection once daily for 48 weeks, followed by brelovitug 300 mg once weekly for the next 48 weeks. Participants are randomly assigned in a 3:1 ratio to these arms to evaluate and compare the treatments over nearly two years. Participants will undergo regular assessments including blood tests to measure viral levels and liver enzymes. Researchers will monitor safety by recording adverse events up to 96 weeks and follow participants after treatment ends. Liver stiffness, quality of life, and other liver function scores will also be evaluated. The main outcome is the percentage of participants achieving virologic response and normalized liver enzymes at 48 weeks. The study aims to provide long-term data on these treatments' effects on chronic HDV infection.
CONDITIONS
Brief Title
A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Diagnosis of chronic HDV infection
- HDV RNA level greater than 500 IU/mL at screening
- Alanine aminotransferase (ALT) level above the upper limit of normal at screening
- Willing to take or already taking HBV nucleos(t)ide therapy
You will not qualify if you...
- Pregnant or nursing females
- Unwilling to comply with contraception requirements during the study
- Difficulty with blood collection or poor venous access for phlebotomy
- Clinical hepatic decompensation such as ascites, encephalopathy, or variceal hemorrhage
- History of solid organ or bone marrow transplantation
- Presence of other liver diseases unrelated to HBV/HDV, including nonalcoholic steatohepatitis (NASH), alcohol-associated hepatitis, cholestatic liver disease, or hepatocellular carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 96 weeks
Participants receive one of two treatment regimens involving subcutaneous injections of brelovitug or bulevirtide followed by brelovitug for chronic hepatitis delta infection.
Weekly visits for participants receiving brelovitug; daily injections of bulevirtide for 48 weeks followed by weekly brelovitug injections for the next 48 weeks with regular monitoring visits
Duration - 24 to 48 weeks post-treatment
Participants are monitored after treatment ends to assess long-term response and safety.
Visits at Weeks 24 and 48 post-treatment
Trial Site Locations
Total: 44 locations
1
Medical University of Graz
Graz, Austria, 8036
Actively Recruiting
2
Universitätsklinikum St. Pölten
Sankt Pölten, Austria, 3100
Actively Recruiting
3
Fakultni Nemocnice Brno
Brno, Brno, Czechia, 62500
Actively Recruiting
4
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia, 500 03
Actively Recruiting
5
Krajská nemocnice Liberec, a.s.
Liberec, Liberec, Czechia, 460 01
Actively Recruiting
6
Institute For Clinical And Experimental Medicine
Prague, Prague, Czechia, 140 00
Actively Recruiting
7
Klin Med s.r.o.
Prague, Prague, Czechia, 2 120 00
Actively Recruiting
8
Hôpital Estaing
Clermont-Ferrand, France, 63000
Actively Recruiting
9
Hôpital Beaujon
Clichy, France, 92110
Actively Recruiting
10
University Hospital Henri Mondor - APHP
Créteil, France, 94000
Actively Recruiting
11
CHU Grenoble Alpes Hopital Nord Michallon
La Tronche, France, 38700
Actively Recruiting
12
Site 512 Centre Hospitalier de Versailles _ Hopital Andre Magnot
Le Chesnay, France, 78157
Not Yet Recruiting
13
University Hospital Limoges
Limoges, France, 87042
Actively Recruiting
14
Hôpital de la Croix-Rousse
Lyon, France, 69004
Actively Recruiting
15
Hôpital Pitié Salpêtrière
Paris, France, 75013
Not Yet Recruiting
16
Centre Hospitalier Universitaire De Rennes
Rennes, France, 35000
Actively Recruiting
17
Hôpital Rangueil
Toulouse, France, 31059
Actively Recruiting
18
Goethe University Frankfurt
Frankfurt, Frankfurt, Germany, 60590
Actively Recruiting
19
Rostock University Medical Center
Rostock, Rostock, Germany, 18057
Actively Recruiting
20
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
21
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
22
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
23
National Institute Of Infectious Diseases
Bucharest, Bucharest, Romania, 021105
Actively Recruiting
24
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
Bucharest, Bucharest, Romania, 030303
Actively Recruiting
25
Centrul Medical Unirea S.R.L
Iași, Lasi, Romania, 700023
Actively Recruiting
26
National Institute of Infectious Diseases Prof Dr Matei Bals
Bucharest, Romania, 021105
Actively Recruiting
27
Spitalul Clinic de Boli Infectioase Constanta
Constanța, Romania, 900709
Actively Recruiting
28
Hospital Universitario Torrecardenas
Almería, Almeria, Spain, 04009
Actively Recruiting
29
Hospital Universitari Vall D Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
30
Hospital Clinic Provincial De Barcelona
Barcelona, Spain, 08036
Actively Recruiting
31
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
32
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
33
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
34
Hospital Universitario Álvaro Cunqueiro
Vigo, Spain, 36312
Actively Recruiting
35
Karolinska University Hospital
Huddinge, Sweden, 14186
Actively Recruiting
36
Hôpitaux Universitaires
Geneva, Canton of Geneva, Switzerland, 1205
Actively Recruiting
37
HOCH Health Ostschweiz
Sankt Gallen, St.Gallen, Switzerland, 95 9007
Actively Recruiting
38
Universitätsspital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
39
Queen Elizabeth Hospital Birmingham
Birmingham, Birmingham, United Kingdom, B15 2GW
Actively Recruiting
40
Chelsea and Westminster Hospital NHS Foundation Trust
London, London, United Kingdom, SW10 9NH
Actively Recruiting
41
North Manchester General Hospital
Manchester, Manchester, United Kingdom, M8 5RB
Actively Recruiting
42
Hull University Teaching Hospitals
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
43
Barts Health NHS Trust
London, United Kingdom, E12ES
Actively Recruiting
44
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
C
Clinical Trials Clinical Trials Mirum
M
Mirum Pharmaceuticals, Inc., Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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