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

NCT07298330 · tracked via the Priya Life Science USA tracker

Sponsor

Mirum Pharmaceuticals, Inc.

Phase

Phase 3

Started

2026-01-14

Last updated

2026-06-29

Condition(s) studied

Chronic Hepatitis D Infection

Investigational drug(s) / intervention(s)

Brelovitug 300 mgBrelovitug 900 mgDelayed Treatment with Brelovitug 300mg

Brelovitug 300 mg: Route of administration- Subcutaneous Injection

Brelovitug 900 mg: Route of administration- Subcutaneous Injection

Delayed Treatment with Brelovitug 300mg: Route of administration- Subcutaneous Injection

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV nucleos(t)ide therapy. Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to comply with contraception requirements during the study 3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). 5. Solid organ or bone marrow transplantation 6. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma. Note - Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm — Week 24
The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (\< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])

Trial sites (27)

Facility	City	Region
University of California, Davis	Davis	California
Kaiser Permanente Medical Center	Sacramento	California
Quest Clinical Research	San Francisco	California
Denver Health Medical Center	Denver	Colorado
Alliance Clinical, Las Vegas	Las Vegas	Nevada
Cleveland Clinic	Cleveland	Ohio
Prime Clinical Research Inc	Mansfield	Texas
University of Utah	Salt Lake City	Utah
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
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

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Other trials for the same condition

A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study) Recruiting

A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07298330 on ClinicalTrials.gov ↗ ← All trials in the USA