A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1)
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Willing and able to provide written informed consent.
• Chronic HDV infection
• HDV RNA \>500 IU/mL at Screening.
• Abnormal ALT (\>upper limit of normal) at Screening.
• Willing to take or already taking HBV nucleos(t)ide therapy
Locations
United States
California
247 Garden Grove
RECRUITING
Garden Grove
242 Huntington Beach
RECRUITING
Huntington Beach
252 Long Beach
RECRUITING
Long Beach
244 Los Angeles
RECRUITING
Los Angeles
Florida
250 Miami
RECRUITING
Miami
Iowa
248 Lowa
RECRUITING
Cities In Iowa
Maryland
254 Baltimore
RECRUITING
Baltimore
New York
245 New York
RECRUITING
New York
253 New York
RECRUITING
New York
255 New York
RECRUITING
New York
256 New York
RECRUITING
New York
Texas
249 San Antonio
RECRUITING
San Antonio
Other Locations
Australia
101 Camperdown
RECRUITING
Camperdown
104 Liverpool
RECRUITING
Liverpool
Bulgaria
705 Plovdiv
RECRUITING
Plovdiv
703 Sliven
RECRUITING
Sliven
702 Bulgaria
RECRUITING
Sofia
706 Sofia
RECRUITING
Sofia
704 Stara Zagora
RECRUITING
Stara Zagora
Georgia
181 Tbilisi
RECRUITING
Tbilisi
182 Tbilisi
RECRUITING
Tbilisi
183 Tbilisi
RECRUITING
Tbilisi
Israel
211 Israel
RECRUITING
Beersheba
New Zealand
001 Auckland
RECRUITING
Auckland
Republic of Moldova
901 Chisinau
RECRUITING
Chisinau
Ukraine
110 Kyiv
RECRUITING
Kyiv
Contact Information
Primary
Bluejay Clinical Trials Information
ClinicalTrials@bluejaytx.com
+1 650 912-5231
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2028-06
Participants
Target number of participants: 150
Treatments
Experimental: Brelovitug 300mg
Dose - brelovitug 300 mg Frequency- once weekly
Experimental: Brelovitug 900mg
Dose - brelovitug 900 mg Frequency- once every 4 weeks
Active_comparator: Delayed Treatment with brelovitug 300mg
Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly
Related Therapeutic Areas
Sponsors
Leads: Bluejay Therapeutics, Inc.