Evaluating BJT-778 for Chronic Hepatitis Delta Infection
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)
This study is testing a new treatment called brelovitug to see if it can safely help people with chronic hepatitis delta virus infection feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bluejay Therapeutics, Inc. Industry-sponsored |
| Locations | 4 sites (Garden Grove, California and 3 other locations) |
| Trial ID | NCT06907290 on ClinicalTrials.gov |
What this trial studies
This Phase 2b/3 study aims to assess the safety and efficacy of brelovitug (BJT-778) for treating chronic hepatitis delta virus (HDV) infection. Participants will be randomized into three groups: one receiving brelovitug weekly, another receiving it monthly, and a third group undergoing a 24-week delayed treatment before starting brelovitug. All participants will undergo regular assessments throughout the study period to monitor their health and response to treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic HDV infection and elevated HDV RNA levels who are willing to comply with study requirements.
Not a fit: Patients with other liver diseases or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from chronic hepatitis delta infection.
How similar studies have performed: Previous studies have shown promise in treating hepatitis infections with similar approaches, but this specific treatment is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Garden Grove, California and 3 other locations
- Garden Grove — Garden Grove, California, United States (Not_yet_recruiting)
- Huntington Beach — Huntington Beach, California, United States (Not_yet_recruiting)
- Walnut Creek — Walnut Creek, California, United States (Not_yet_recruiting)
- Chisinau — Chisinau, Moldova, Republic of (Recruiting)
Study contacts
- Study coordinator: Bluejay Clinical Trials Information
- Email: ClinicalTrials@bluejaytx.com
- Phone: +1 650 912-5231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.