A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
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 neucleos(t)ide therapy.
Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
United Kingdom
Hull University Teaching Hospitals
RECRUITING
Cottingham
Barts Health NHS Trust
RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Bluejay Clinical Trials Information
ClinicalTrials@bluejaytx.com
+16509125231
Time Frame
Start Date: 2025-08-27
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 172
Treatments
Experimental: Brelovitug
Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Active_comparator: Bulevirtide for 48 weeks followed by brelovitug for 48 weeks
Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.
Related Therapeutic Areas
Sponsors
Leads: Bluejay Therapeutics, Inc.