A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
Running, not enrolling · Phase 3
Conditions studied: Chronic Hepatitis D Infection
In brief
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.
Key facts
- Study ID
- NCT07298330
- Run by
- Mirum Pharmaceuticals, Inc.
- People needed
- 80
- Starts
- 2026-01-14
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willing and able to provide written informed consent
- Chronic HDV infection
- HDV RNA >500 IU/mL at Screening
- ALT >ULN at Screening
- Willing to take or already taking HBV nucleos(t)ide therapy.
You may not qualify if…
- Pregnant or nursing females
- Unwilling to comply with contraception requirements during the study
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- Solid organ or bone marrow transplantation
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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