A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection AZURE-4

What this Trial Is About

Researchers are conducting a Phase 3 global clinical trial to evaluate the safety and effectiveness of brelovitug BJT-778 in treating chronic hepatitis delta virus HDV infection. This study compares brelovitug treatment to delayed treatment to understand its impact on viral response and liver enzyme normalization. The trial is randomized, open-label, and involves multiple centers worldwide. The trial includes three treatment groups. One group receives brelovitug 300 mg by subcutaneous injection once weekly for 96 weeks. Another group receives brelovitug 900 mg by subcutaneous injection once every 4 weeks with a loading dose at Week 2 for the same duration. The third group delays brelovitug treatment for 12 weeks, then receives 300 mg weekly injections for 96 weeks. Participants will attend clinic visits for treatment and monitoring over the study period. Researchers will assess viral response using HDV RNA levels, liver enzyme ALT normalization, and other liver health measures. Safety will be monitored through adverse event tracking up to 96 weeks. The primary outcome is the percentage of participants achieving combined viral and ALT response at Week 24 compared to delayed treatment at Week 12. Follow-up includes liver stiffness and disease progression assessments.

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)