RecruitingChronic Hepatitis D Infection
A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
Eligible age
18–99 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: Mirum Pharmaceuticals, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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 liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
- ✕ Note - Other protocol-defined Inclusion/Exclusion criteria apply.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07298330 · last updated 2026-03-02