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 (10) 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
Quest Clinical Research
RECRUITING
San Francisco
Nevada
Alliance Clinical, Las Vegas
RECRUITING
Las Vegas
Texas
Prime Clinical Research Inc
RECRUITING
Mansfield
Other Locations
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
Israel
Soroka University Medical Center
RECRUITING
Beersheba
Pakistan
Aga Khan University & Hospital
RECRUITING
Karachi
Contact Information
Primary
Bluejay Clinical Trials Information
ClinicalTrials@bluejaytx.com
6509125231
Backup
Bluejay Therapeutics Study Director
Time Frame
Start Date: 2025-12
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: Bluejay Therapeutics, Inc.