Phase 3 Global Study Comparing Brelovitug and Bulevirtide for Treating Chronic Hepatitis Delta Infection

What this Trial Is About

This trial is a global, Phase 3, randomized, open-label study comparing brelovitug BJT-778 and bulevirtide for treating chronic hepatitis delta infection CHD. The main aim is to evaluate the long-term effectiveness of brelovitug versus bulevirtide in patients with chronic HDV infection. Approximately 172 participants will enroll to assess these treatments over an extended period. Participants are randomly assigned in a 31 ratio to one of two treatment arms. In the first arm, participants receive brelovitug 300 mg as a weekly subcutaneous injection for 96 weeks. In the second arm, participants receive bulevirtide 2 mg daily by subcutaneous injection for 48 weeks, followed by brelovitug 300 mg weekly for an additional 48 weeks. This design allows comparison of brelovitug alone to sequential treatment starting with bulevirtide. During the study, participants will have regular assessments including monitoring of viral load, liver enzymes, liver health markers, and quality of life questionnaires. Researchers will track treatment response, safety, adverse events, and liver disease progression over up to 96 weeks of treatment and follow-up. The main outcome measured is the percentage of participants achieving viral control and normalized liver enzyme levels at 48 weeks, with additional evaluations continuing through 96 weeks and post-treatment follow-up periods.

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