Status:
RECRUITING
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
Lead Sponsor:
Bluejay Therapeutics, Inc.
Conditions:
Chronic Hepatitis D Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 t...
Detailed Description
Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms: * Arm 1: Participants randomized to Arm 1 will receive brelovitug 3...
Eligibility Criteria
Inclusion
- 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
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
- Presence of other liver disease(s) (does not include HBV or HDV infection) such as non-alcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
- Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- Solid organ or bone marrow transplantation Note: other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06907290
Start Date
March 25 2025
End Date
June 1 2028
Last Update
January 7 2026
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
247 Garden Grove
Garden Grove, California, United States, 92840
2
242 Huntington Beach
Huntington Beach, California, United States, 92647
3
252 Long Beach
Long Beach, California, United States, 90805
4
244 Los Angeles
Los Angeles, California, United States, 90033