A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
NCT ID: NCT07298330
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2025-12-31
2029-01-31
Brief Summary
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Detailed Description
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Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Arm 2: Participants will receive brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks.
Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brelovitug 300 mg
Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Brelovitug 300 mg
Route of administration- Subcutaneous Injection
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
Brelovitug 900 mg
Route of administration- Subcutaneous Injection
Delayed treatment with brelovitug 300 mg
Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks
Delayed Treatment with Brelovitug 300mg
Route of administration- Subcutaneous Injection
Interventions
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Brelovitug 300 mg
Route of administration- Subcutaneous Injection
Brelovitug 900 mg
Route of administration- Subcutaneous Injection
Delayed Treatment with Brelovitug 300mg
Route of administration- Subcutaneous Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic HDV infection
3. HDV RNA \>500 IU/mL at Screening
4. ALT \>ULN at Screening
5. Willing to take or already taking HBV nucleos(t)ide therapy.
Exclusion Criteria
2. Unwilling to comply with contraception requirements during the study
3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
5. Solid organ or bone marrow transplantation
6. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
18 Years
99 Years
ALL
No
Sponsors
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Bluejay Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California, Davis
Davis, California, United States
Quest Clinical Research
San Francisco, California, United States
Alliance Clinical, Las Vegas
Las Vegas, Nevada, United States
Prime Clinical Research Inc
Mansfield, Texas, United States
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
Soroka University Medical Center
Beersheba, , Israel
Aga Khan University & Hospital
Karachi, Karachi, Pakistan
Countries
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Central Contacts
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Bluejay Therapeutics Study Director
Role: CONTACT
Other Identifiers
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2025-522105-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
BJT-778-304
Identifier Type: -
Identifier Source: org_study_id