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Active, Not Recruiting

NCT Number: NCT07298330

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasme Hospital, Brussels, Belgium

Loading trial locations.

About this study

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.

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
  • ALT >ULN 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
  • Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
  • Solid organ or bone marrow transplantation
  • 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.

Treatment and study plan

Brelovitug 300 mg

Drug

Route of administration- Subcutaneous Injection

Other names: BJT-778, BTG

Brelovitug 900 mg

Drug

Route of administration- Subcutaneous Injection

Other names: BJT-778, BTG

Delayed Treatment with Brelovitug 300mg

Drug

Route of administration- Subcutaneous Injection

Other names: BJT-778, BTG

Primary outcomes

  1. 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

    Time frame: Week 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])

Secondary outcomes

  1. Percentage of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to 96 weeks

    An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.

  2. Percentage of participants who discontinue treatment due to an adverse event (AE)

    Time frame: Up to 96 weeks

    An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.

  3. Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND

    Time frame: Up to 96 Weeks

  4. Percentage of participants with HDV RNA <LLOQ

    Time frame: Up to 96 Weeks

  5. Percentage of participants with HDV RNA <LLOQ, TND

    Time frame: Up to 96 Weeks

  6. Percentage of participants with ALT normalization

    Time frame: Up to 96 Weeks

    ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN

  7. Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or <LLOQ, TND

    Time frame: Up to 96 Weeks

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND.

  8. Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ

    Time frame: Up to 96 Weeks

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA <LLOQ

  9. Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND

    Time frame: Up to 96 Weeks

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA <LLOQ, TND.

  10. Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.

    Time frame: Post-Treatment Weeks 24 and 48

  11. Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan)

    Time frame: Up to 96 Weeks

  12. Change from baseline in APRI (AST-to-platelet ratio index)

    Time frame: Up to 96 Weeks

  13. Change from baseline in CTP score in participants with cirrhosis

    Time frame: Up to 96 Weeks

  14. Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis

    Time frame: Up to 96 Weeks

  15. Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease.

    Time frame: Up to 96 Weeks

    Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC).

Sponsors and collaborators

Lead sponsor

Mirum Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Dec 23, 2025
Registry last updated
Jun 29, 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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