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

February 26, 2026 updated by: Mirum Pharmaceuticals, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms:

  • Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly.
  • Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks.
  • Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Camperdown, Australia
        • 101 Camperdown
      • Liverpool, Australia
        • 104 Liverpool
    • Victoria
      • Melbourne, Victoria, Australia
        • 102 Melbourne
  • Bulgaria
      • Plovdiv, Bulgaria
        • 705 Plovdiv
      • Sofia, Bulgaria
        • 702 Bulgaria
      • Sofia, Bulgaria
        • 706 Sofia
      • Stara Zagora, Bulgaria
        • 704 Stara Zagora
    • Silven
      • Sliven, Silven, Bulgaria, 8800
        • 703 Sliven
  • Canada
    • Calgary
      • Calgary, Calgary, Canada
        • 233 Calgary
    • Edmonton
      • Edmonton, Edmonton, Canada, T6G 2G5
        • 234 Alberta
    • Ontario
      • Toronto, Ontario, Canada
        • 231 Toronto
    • Quebec
      • Montreal, Quebec, Canada
        • 235 Montreal
  • Georgia
      • Tbilisi, Georgia, 0105
        • 181 Tbilisi
      • Tbilisi, Georgia, 0105
        • 183 Tbilisi
      • Tbilisi, Georgia
        • 182 Tbilisi
  • Israel
      • Beersheba, Israel
        • 211 Israel
    • Haifa District
      • Haifa, Haifa District, Israel
        • 212 Haifa
  • Moldova
      • Chisinau, Moldova
        • 901 Chisinau
  • New Zealand
      • Auckland, New Zealand
        • 001 Auckland
  • Pakistan
    • Karachi
      • Karachi, Karachi, Pakistan
        • 221 Karachi City
  • Serbia
    • Belgrade
      • Belgrade, Belgrade, Serbia
        • 291 Belgrade
  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye)
        • 191 Istanbul
  • Ukraine
      • Kyiv, Ukraine, 01001
        • 110 Kyiv
  • United States
    • California
      • Garden Grove, California, United States, 92840
        • 247 Garden Grove
      • Huntington Beach, California, United States, 92647
        • 242 Huntington Beach
      • Long Beach, California, United States, 90805
        • 252 Long Beach
      • Los Angeles, California, United States, 90033
        • 244 Los Angeles
    • Florida
      • Miami, Florida, United States, 33166
        • 250 Miami
    • Illinois
      • Chicago, Illinois, United States, 60612
        • 251, Illinois
    • Iowa
      • Cities in Iowa, Iowa, United States, 52242
        • 248 Lowa
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • 254 Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • 241, Massachusetts
    • New York
      • New York, New York, United States, 10007
        • 245 New York
      • New York, New York, United States, 10065
        • 256 New York
      • New York, New York, United States, 10075
        • 253 New York
      • New York, New York, United States, 10075
        • 255 New York
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • 257 Philadelphia
    • Texas
      • San Antonio, Texas, United States, 78215
        • 249 San Antonio

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brelovitug 300mg
Dose - brelovitug 300 mg Frequency- once weekly
Drug: Brelovitug 300 mg
Route of administration- Subcutaneous Injection
Experimental: Brelovitug 900mg
Dose - brelovitug 900 mg Frequency- once every 4 weeks
Drug: Brelovitug 900 mg
Route of administration- Subcutaneous Injection
Active Comparator: Delayed Treatment with brelovitug 300mg
Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly
Drug: Delayed Treatment with Brelovitug 300mg
Route of administration- Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with a composite endpoint
Time Frame: Week 24
Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS
Time Frame: Weeks 24, 48, 96, and 120, if applicable
Frequency and severity of TEAEs and serious AEs
Weeks 24, 48, 96, and 120, if applicable
Percentage of participants that achieve that achieve virologic response and ALT normalization
Time Frame: Weeks 24, 48, 96, and 120, if applicable
Change from baseline in HDV RNA and ALT normalization
Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with a composite endpoint by treatment regimen
Time Frame: Weeks 24, 48, 96, and 120, if applicable
Compare the composite endpoint response (change from baseline HDV RNA and ALT normalization) between weekly versus every 4-week regimen of brelovitug
Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with HDV associated liver disease progression
Time Frame: Weeks 24, 48, 96, and 120, if applicable
Determined by an independent data monitoring committee based on changes in liver stiffness, APRI, CPT/MELD score (cirrhotic), and TEAEs.
Weeks 24, 48, 96, and 120, if applicable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mirum Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bluejay Therapeutics, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BJT-778-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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