RECRUITING

A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.

Official Title

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)

Quick Facts

Study Start:2025-03-25
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06907290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide written informed consent.
  2. * Chronic HDV infection
  3. * HDV RNA \>500 IU/mL at Screening.
  4. * Abnormal ALT (\>upper limit of normal) at Screening.
  5. * Willing to take or already taking HBV nucleos(t)ide therapy
  1. * Pregnant or nursing females.
  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. * 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.
  5. * Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
  6. * Solid organ or bone marrow transplantation Note: other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Study Contact

Bluejay Clinical Trials Information
CONTACT
+1 650 912-5231
ClinicalTrials@bluejaytx.com

Principal Investigator

Bluejay Therapeutics
STUDY_DIRECTOR
Bluejay Therapeutics

Study Locations (Sites)

Garden Grove
Garden Grove, California, 92840
United States
Huntington Beach
Huntington Beach, California, 92647
United States
Walnut Creek
Walnut Creek, California, 94598
United States

Collaborators and Investigators

Sponsor: Bluejay Therapeutics, Inc.

  • Bluejay Therapeutics, STUDY_DIRECTOR, Bluejay Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Hepatitis Delta virus; HDV; hepatitis D infection; hepatitis D virus

Additional Relevant MeSH Terms

  • Chronic Hepatitis D Infection