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A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

RECRUITINGPhase 3Sponsored by Mirum Pharmaceuticals, Inc.
Actively Recruiting
PhasePhase 3
SponsorMirum Pharmaceuticals, Inc.
Started2025-08-27
Est. completion2027-06-30
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07200908

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

Age: 18 Years – 99 YearsHealthy volunteers accepted
Key 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 neucleos(t)ide therapy.

Key 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 liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.

Note - Other protocol-defined Inclusion/Exclusion criteria apply.

Conditions2

Chronic Hepatitis D InfectionLiver Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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