A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
Mirum Pharmaceuticals, Inc.
Summary
This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.
Description
The study consists of 3 study arms. Approximately 80 participants will be randomized 2:1:1 to one of the following treatment arms: Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks. Arm 2: Participants will receive brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks. Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV nucleos(t)ide therapy. Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to comply with contraception requirements during the study 3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). 5. Solid organ or bone marrow transplantation 6. Presence of other…
Interventions
- DrugBrelovitug 300 mg
Route of administration- Subcutaneous Injection
- DrugBrelovitug 900 mg
Route of administration- Subcutaneous Injection
- DrugDelayed Treatment with Brelovitug 300mg
Route of administration- Subcutaneous Injection
Locations (27)
- University of California, DavisDavis, California
- Kaiser Permanente Medical CenterSacramento, California
- Quest Clinical ResearchSan Francisco, California
- Denver Health Medical CenterDenver, Colorado
- Alliance Clinical, Las VegasLas Vegas, Nevada
- Cleveland ClinicCleveland, Ohio