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

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.

Conditions

Chronic Hepatitis D Infection

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Chronic Hepatitis D Infection
Intervention / Treatment

-

Contacts and Locations

Garden Grove

Garden Grove, Garden Grove, California, United States, 92840

Huntington Beach

Huntington Beach, Huntington Beach, California, United States, 92647

Walnut Creek

Walnut Creek, Walnut Creek, California, United States, 94598

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bluejay Therapeutics, Inc.,

Bluejay Therapeutics, STUDY_DIRECTOR, Bluejay Therapeutics

Study Record Dates

2028-06