A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California, Davis
RECRUITING
Davis
Kaiser Permanente Medical Center
RECRUITING
Sacramento
Quest Clinical Research
RECRUITING
San Francisco
Colorado
Denver Health Medical Center
RECRUITING
Denver
Nevada
Alliance Clinical, Las Vegas
RECRUITING
Las Vegas
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Texas
Prime Clinical Research Inc
RECRUITING
Mansfield
Utah
University of Utah
RECRUITING
Salt Lake City
Other Locations
Belgium
Erasme Hospital
RECRUITING
Brussels
University Hospital Antwerp (UZA)
RECRUITING
Edegem
University Hospital Center Sart-Tilman
RECRUITING
Liège
Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda
RECRUITING
Sofia
Georgia
Hospital Service LTD
RECRUITING
Kutaisi
Diakori LLC
RECRUITING
Tbilisi
JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center
RECRUITING
Tbilisi
LTD Academician Vakhtang Bochorishvili Clinic
RECRUITING
Tbilisi
Hungary
Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases
RECRUITING
Budapest
Fejer County St. Gyorgy University Teaching Hospital
RECRUITING
Székesfehérvár
Israel
Soroka University Medical Center
RECRUITING
Beersheba
HaEmek Medical Center
RECRUITING
Haifa
Pakistan
Aga Khan University & Hospital
RECRUITING
Karachi
Taiwan
E-Da Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
National Taiwan University Hospital
RECRUITING
Taipei
Ukraine
Limited Liability Company Medical Center Health and Rehabilitation 100 Percent Life
RECRUITING
Poltava
Public Non-Profit Enterprise Central City Hospital of Rivne City Council
RECRUITING
Rivne
Uzbekistan
Research Institute of Virology of the Republic of Uzbekistan
RECRUITING
Tashkent
Contact Information
Primary
Clinical Trials Mirum
clinicaltrials@mirumpharma.com
+16506674085
Backup
Mirum Pharmaceuticals, Inc., Clinical Trials
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2029-01
Participants
Target number of participants: 80
Treatments
Experimental: Brelovitug 300 mg
Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Experimental: Brelovitug 900 mg
Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks
Active_comparator: Delayed treatment with brelovitug 300 mg
Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks
Related Therapeutic Areas
Sponsors
Leads: Mirum Pharmaceuticals, Inc.