Clinical Trial

A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

Active, Not Recruiting Phase 2/3
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Summary
This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2025-03-26; most recent amendment 2026-02-26.
Status change: Recruiting → Active, Not Recruiting 2026-02-24
Trial Details
NCT Number NCT06907290
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions Chronic Hepatitis D Infection
Enrollment 150 participants
Start Date 2025-03-25
Primary Completion 2029-05 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-02