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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)

Clinical Trial Details

 The primary objective of the study is to evaluate the effectiveness and safety of brelovitug (BJT-778) as a long-term treatment in participants with chronic hepatitis delta virus (HDV) infection, the virus responsible for chronic hepatitis D (CHD).

BJT-778 is an investigational study drug, which  means that it is not an approved treatment for HDV infection by the U.S. Food and Drug Administration (FDA)    

Eligible participants are randomly assigned to one of 3 different groups. Group 1 will receive BJT-778 300 mg once per week for 96 weeks, Group 2 will receive BJT-778 900 mg once every 2 weeks for 4 weeks, then every 4 weeks for 92 weeks, and Group 3 will delay treatment for 24 weeks, after which BJT-778 300mg will be self-administered once a week for 96 weeks.

If assigned to Group 1 or 2, participants will be in the study for 105 weeks. If assigned to Group 3, participants will be in the study for 129 weeks.

The main study procedures include study drug injection (at the intervals designated by the participant’s group) and liver scans (FibroScan and ultrasound).

Key Eligibility: 

1. Open to all adults ages 18 and older who have chronic HDV infection.

Detailed eligibility will be reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Allysa Saggese, NP
(646) 962-5483
als9267@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2504028720

ClinicalTrials.gov:

NCT06907290

Sponsor:

BJT-778-301

Status

Open to Enrollment

Age Group

Adult

Sponsor