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NCT Number: NCT06907290

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Hepatitis D Infection Digestive System Diseases Hepatitis Hepatitis D Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

102 Melbourne, Melbourne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brelovitug 300 mg

Drug

Route of administration- Subcutaneous Injection

Brelovitug 900 mg

Drug

Route of administration- Subcutaneous Injection

Delayed Treatment with Brelovitug 300mg

Drug

Route of administration- Subcutaneous Injection

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Mirum Pharmaceuticals, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 2, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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