RecruitingPhase 3NCT07298330

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

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

Sponsor

Mirum Pharmaceuticals, Inc.

Enrollment

80 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis D Infection

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Brelovitug 300 mg, a drug called Brelovitug 900 mg, and others for people with chronic hepatitis d infection. The study is currently recruiting participants at 27 locations. People eligible for this study include aged 18 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrelovitug 300 mg

Route of administration- Subcutaneous Injection

DRUGBrelovitug 900 mg

Route of administration- Subcutaneous Injection

DRUGDelayed Treatment with Brelovitug 300mg

Route of administration- Subcutaneous Injection

Locations(27)

University of California, Davis

Davis, California, United States

Kaiser Permanente Medical Center

Sacramento, California, United States

Quest Clinical Research

San Francisco, California, United States

Denver Health Medical Center

Denver, Colorado, United States

Alliance Clinical, Las Vegas

Las Vegas, Nevada, United States

Cleveland Clinic

Cleveland, Ohio, United States

Prime Clinical Research Inc

Mansfield, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Erasme Hospital

Brussels, Belgium

University Hospital Antwerp (UZA)

Edegem, Belgium

University Hospital Center Sart-Tilman

Liège, Belgium

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda

Sofia, Bulgaria

Hospital Service LTD

Kutaisi, Georgia

Diakori LLC

Tbilisi, Georgia

JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, Georgia

LTD Academician Vakhtang Bochorishvili Clinic

Tbilisi, Georgia

Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases

Budapest, Hungary

Fejer County St. Gyorgy University Teaching Hospital

Székesfehérvár, Hungary

Soroka University Medical Center

Beersheba, Israel

HaEmek Medical Center

Haifa, Israel

Aga Khan University & Hospital

Karachi, Karachi, Pakistan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

E-Da Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Limited Liability Company "Medical Center Health and Rehabilitation "100 Percent Life"

Poltava, Ukraine

Public Non-Profit Enterprise "Central City Hospital" of Rivne City Council

Rivne, Ukraine

Research Institute of Virology of the Republic of Uzbekistan

Tashkent, Uzbekistan

View Full Details on ClinicalTrials.gov

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NCT07298330

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