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

NCT07200908 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2026-03-27

No results posted yet for this study

Summary

This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.

Conditions

  • Chronic Hepatitis D Infection

Interventions

DRUG

Brelovitug 300 mg

Route of administration- Subcutaneous Injection

DRUG

Bulevirtide 2 mg and Brelovitug - 300 mg

Route of Administration- Subcutaneous Injection

Sponsors & Collaborators

  • Mirum Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2027-06-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Italy
  • Romania
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07200908 on ClinicalTrials.gov