A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
NCT ID: NCT07200908
Last Updated: 2025-12-22
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
172 participants
INTERVENTIONAL
2025-08-27
2029-09-30
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 bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 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
Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Brelovitug 300 mg
Route of administration- Subcutaneous Injection
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.
Bulevirtide 2 mg and Brelovitug - 300 mg
Route of Administration- Subcutaneous Injection
Interventions
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Brelovitug 300 mg
Route of administration- Subcutaneous Injection
Bulevirtide 2 mg and Brelovitug - 300 mg
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 neucleos(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 nonalcoholic steatohepatitis (NASH), 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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Principal Investigators
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Bluejay Therapeutics
Role: STUDY_DIRECTOR
Bluejay Therapeutics
Locations
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Medical University of Graz
Graz, , Austria
Fakultni Nemocnice Brno
Brno, Brno, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
Institute For Clinical And Experimental Medicine
Prague, Prague, Czechia
Klin Med s.r.o.
Prague, Prague, Czechia
Goethe University Frankfurt
Frankfurt, Frankfurt, Germany
Rostock University Medical Center
Rostock, Rostock, Germany
National Institute Of Infectious Diseases
Bucharest, Bucharest, Romania
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
Bucharest, Bucharest, Romania
Centrul Medical Unirea S.R.L
Iași, Lasi, Romania
Hospital Universitario Torrecardenas
Almería, Almeria, Spain
Hospital Universitari Vall D Hebron
Barcelona, Barcelona, Spain
Queen Elizabeth Hospital Birmingham
Birmingham, Birmingham, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, London, United Kingdom
Hull University Teaching Hospitals
Cottingham, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-517167-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
BJT-778-302
Identifier Type: -
Identifier Source: org_study_id