Status:
RECRUITING
A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
Lead Sponsor:
Bluejay Therapeutics, Inc.
Conditions:
Chronic Hepatitis D Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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...
Detailed Description
Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 to one of the following treatment arms: Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly f...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- Pregnant or nursing females
- Unwilling to comply with contraception requirements during the study
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- Solid organ or bone marrow transplantation
- Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
- Note - Other protocol-defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT07200908
Start Date
August 27 2025
End Date
September 30 2029
Last Update
December 22 2025
Active Locations (17)
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1
Medical University of Graz
Graz, Austria, 8036
2
Fakultni Nemocnice Brno
Brno, Brno, Czechia, 62500
3
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia, 500 03
4
Institute For Clinical And Experimental Medicine
Prague, Prague, Czechia, 140 00