Actively Recruiting
A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
Led by Mirum Pharmaceuticals, Inc. · Updated on 2026-03-02
80
Participants Needed
27
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 3 global clinical trial to evaluate the safety and effectiveness of brelovitug (BJT-778) in treating chronic hepatitis delta virus (HDV) infection. This study compares brelovitug treatment to delayed treatment to understand its impact on viral response and liver enzyme normalization. The trial is randomized, open-label, and involves multiple centers worldwide. The trial includes three treatment groups. One group receives brelovitug 300 mg by subcutaneous injection once weekly for 96 weeks. Another group receives brelovitug 900 mg by subcutaneous injection once every 4 weeks with a loading dose at Week 2 for the same duration. The third group delays brelovitug treatment for 12 weeks, then receives 300 mg weekly injections for 96 weeks. Participants will attend clinic visits for treatment and monitoring over the study period. Researchers will assess viral response using HDV RNA levels, liver enzyme (ALT) normalization, and other liver health measures. Safety will be monitored through adverse event tracking up to 96 weeks. The primary outcome is the percentage of participants achieving combined viral and ALT response at Week 24 compared to delayed treatment at Week 12. Follow-up includes liver stiffness and disease progression assessments.
CONDITIONS
Brief Title
A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Diagnosis of chronic hepatitis delta virus (HDV) infection
- HDV RNA greater than 500 IU/mL at screening
- Alanine aminotransferase (ALT) level above the upper limit of normal at screening
- Willing to take or currently taking hepatitis B virus nucleos(t)ide therapy
You will not qualify if you...
- Pregnant or nursing females
- Unwillingness 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 besides HBV/HDV, including metabolic dysfunction-associated steatohepatitis (MASH), 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 108 weeks depending on arm
Participants receive brelovitug treatment by subcutaneous injection in one of three ways depending on their assigned arm: 300 mg once weekly for 96 weeks, 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks, or delayed treatment with brelovitug 300 mg starting at Week 12 once weekly for 96 weeks.
Weekly or monthly visits depending on treatment arm over up to 108 weeks
Trial Site Locations
Total: 27 locations
1
University of California, Davis
Davis, California, United States, 95616
Actively Recruiting
2
Kaiser Permanente Medical Center
Sacramento, California, United States, 95661
Actively Recruiting
3
Quest Clinical Research
San Francisco, California, United States, 94115
Actively Recruiting
4
Denver Health Medical Center
Denver, Colorado, United States, 80204
Actively Recruiting
5
Alliance Clinical, Las Vegas
Las Vegas, Nevada, United States, 89019
Actively Recruiting
6
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
Prime Clinical Research Inc
Mansfield, Texas, United States, 76063
Actively Recruiting
8
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
9
Erasme Hospital
Brussels, Belgium
Actively Recruiting
10
University Hospital Antwerp (UZA)
Edegem, Belgium
Actively Recruiting
11
University Hospital Center Sart-Tilman
Liège, Belgium
Actively Recruiting
12
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda
Sofia, Bulgaria, 1407
Actively Recruiting
13
Hospital Service LTD
Kutaisi, Georgia, 4608
Actively Recruiting
14
Diakori LLC
Tbilisi, Georgia, 0159
Actively Recruiting
15
JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, Georgia, 0159
Actively Recruiting
16
LTD Academician Vakhtang Bochorishvili Clinic
Tbilisi, Georgia, 0160
Actively Recruiting
17
Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases
Budapest, Hungary, H-1097
Actively Recruiting
18
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár, Hungary, H-8000
Actively Recruiting
19
Soroka University Medical Center
Beersheba, Israel, 8410101
Actively Recruiting
20
HaEmek Medical Center
Haifa, Israel, 3296043
Actively Recruiting
21
Aga Khan University & Hospital
Karachi, Karachi, Pakistan, 74800
Actively Recruiting
22
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807377
Actively Recruiting
23
E-Da Hospital
Kaohsiung City, Taiwan, 82445
Actively Recruiting
24
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
25
Limited Liability Company "Medical Center Health and Rehabilitation "100 Percent Life"
Poltava, Ukraine, 36000
Actively Recruiting
26
Public Non-Profit Enterprise "Central City Hospital" of Rivne City Council
Rivne, Ukraine, 33018
Actively Recruiting
27
Research Institute of Virology of the Republic of Uzbekistan
Tashkent, Uzbekistan, 100194
Actively Recruiting
Research Team
C
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
3
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