This study is in progress, not accepting new patients

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

a study on Hepatitis D

Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at Davis, California and other locations
Dates
study started
study ends around

Description

Summary

This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.

Official Title

A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

Details

The study consists of 3 study arms. Approximately 80 participants will be randomized 2:1:1 to one of the following treatment arms:

Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.

Arm 2: Participants will receive brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks.

Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.

Keywords

Chronic Hepatitis D Infection, Hepatitis Delta virus, HDV, Hepatitis D infection, Hepatitis D virus, Hepatitis D, Treatment Delay, Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg

Eligibility

You can join if…

Open to people ages 18-99

  1. Willing and able to provide written informed consent
  2. Chronic HDV infection
  3. HDV RNA >500 IU/mL at Screening
  4. ALT >ULN at Screening
  5. Willing to take or already taking HBV nucleos(t)ide therapy.

You CAN'T join if...

  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. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
  5. Solid organ or bone marrow transplantation
  6. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.

Note - Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • University of California, Davis
    Davis California 95616 United States
  • Kaiser Permanente Medical Center
    Sacramento California 95661 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirum Pharmaceuticals, Inc.
ID
NCT07298330
Phase
Phase 3 Hepatitis D Research Study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated