Back to search results

Brelovitug for Chronic Hepatitis Delta Infection (AZURE-4)

This study is testing a new treatment called brelovitug for people with chronic hepatitis delta (HDV) infection. Brelovitug is given as a shot under the skin. Researchers want to see how safe and effective brelovitug is compared to delaying treatment. You might be able to join if you are between 18 and 99 years old, have chronic HDV infection with a certain level of HDV RNA (a measure of the virus in your blood) and elevated ALT (a liver enzyme), and are willing to take or are already taking medication for hepatitis B (HBV). The main goal is to see how many participants have a good response to treatment after 24 weeks, which includes a drop in the virus and normal liver enzyme levels. The study is currently recruiting about 80 participants.

Study design
This is a global, randomized study where participants are assigned by chance to one of three treatment groups. It is an open-label study, meaning both you and the study team will know which treatment you are receiving.
What's involved
Participants will receive brelovitug injections once weekly or once every four weeks for 96 weeks, or delay treatment for 12 weeks before starting brelovitug for 96 weeks. You will also attend study clinic visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring treatment success is at Week 24.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07298330

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

Active, Not Recruiting
PHASE3Ages 18–99InterventionalTreatment
Mirum Pharmaceuticals, Inc.
~80 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Brelovitug 300 mgBrelovitug 900 mgDelayed Treatment with Brelovitug 300mg

At a glance

Recruiting sites
0 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm
Measured over Week 24

Conditions

Chronic Hepatitis D Infection

Explore related trials

Viral hepatitis DHDV RNA

Where it's being run

27 sites across 15 states
Georgia4
California3
Belgium3
Taiwan3
Hungary2
Israel2
Ukraine2
Colorado1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment armWeek 24

    The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (\< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])