A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
Mirum Pharmaceuticals, Inc.
172 participants
Aug 27, 2025
INTERVENTIONAL
Conditions
Summary
This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
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 neucleos(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 nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
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Interventions
Route of administration- Subcutaneous Injection
Route of Administration- Subcutaneous Injection
Locations(44)
View Full Details on ClinicalTrials.gov
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NCT07200908