drugset / Trial / NCT06907290

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

NCT06907290

Phase 2/3 Active not recruiting 150 enrolled Mirum Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-03-25
Primary completion
2029-05
Completion
2029-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Brelovitug Unknown 300 mg Subcutaneous
Subject Brelovitug Unknown 900 mg Subcutaneous