NCT06907290

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

A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1)

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms: * Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly. * Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks. * Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.

Conditions

• Chronic Hepatitis D Infection

Interventions

Type	Name	Description
DRUG	Brelovitug 300 mg	Route of administration- Subcutaneous Injection
DRUG	Brelovitug 900 mg	Route of administration- Subcutaneous Injection
DRUG	Delayed Treatment with Brelovitug 300mg	Route of administration- Subcutaneous Injection

Timeline

• Start date: 2025-03-25
• Primary completion: 2029-05-01
• Completion: 2029-09-01
• First posted: 2025-04-02
• Last updated: 2026-03-02

Locations

38 sites across 12 countries: United States, Australia, Bulgaria, Canada, Georgia, Israel, Moldova, New Zealand, Pakistan, Serbia, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study