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

NCT07298330 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-02

No results posted yet for this study

Summary

This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.

Conditions

  • Chronic Hepatitis D Infection

Interventions

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

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
2026-01-14
Primary Completion
2026-08-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Georgia
  • Hungary
  • Israel
  • Pakistan
  • Taiwan
  • Ukraine
  • Uzbekistan

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 NCT07298330 on ClinicalTrials.gov