A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
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.
80 participants
Jan 14, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 nucleos(t)ide therapy.
Exclusion Criteria6
- Pregnant or nursing females
- Unwilling to comply with contraception requirements during the study
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- Solid organ or bone marrow transplantation
- Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
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Interventions
Route of administration- Subcutaneous Injection
Route of administration- Subcutaneous Injection
Route of administration- Subcutaneous Injection
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT07298330