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NCT Number: NCT07454837

Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

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Key information

Conditions

Chronic Hepatitis D Chronic Disease Digestive System Diseases Disease Attributes Hepatitis Hepatitis D Hepatitis D, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms 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

Medical University of Graz, Graz, Austria

Loading trial locations.

About this study

This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).

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.
  • Male or female, ≥18 years of age at Screening.
  • Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
  • Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
  • HDV RNA ≥100 IU/mL at Screening.

Exclusion criteria

  • Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).
  • Known history of immune-complex disease.
  • Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
  • Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).
  • History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.

Treatment and study plan

Brelovitug (BJT-778)

Drug

Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.

Other names: BJT-778

Bulevirtide

Drug

Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.

Other names: BJT-778, Hepcludex

Primary outcomes

  1. Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])

    Time frame: Week 24

    The proportion of participants with undetectable HDV RNA (<LLOQ, TND) at Week 24

Secondary outcomes

  1. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Time frame: Up to Week 96

    Incidence and severity of treatment-emergent adverse events (TEAEs) during brelovitug and bulevirtide treatment periods.

  2. Proportion of participants who permanently discontinue treatment due to an adverse event

    Time frame: Up to Week 96

    Proportion of participants who permanently discontinue study treatment because of an adverse event.

  3. Change from baseline in serum total bile salts

    Time frame: Up to Week 96

    Mean change from baseline in serum total bile salt levels.

  4. Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)

    Time frame: Up to Week 96

    Proportion of participants with virologic response at Weeks 24, 48, 72, and 96.

  5. Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.

    Time frame: Up to Week 96

  6. Proportion of participants achieving undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96.

    Time frame: Up to Week 96

  7. Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96.

    Time frame: Up to Week 96

  8. Proportion of participants achieving normal ALT with virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)

    Time frame: Up to Week 96

    Proportion of participants with normal ALT and virologic response at Weeks 24, 48, 72, and 96.

  9. Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96.

    Time frame: Up to Week 96

  10. 11. Proportion of participants achieving normal ALT with undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96

    Time frame: Up to Week 96

  11. Change from baseline in HDV RNA

    Time frame: Up to Week 96

    Change from baseline in HDV RNA levels over time during treatment.

  12. Change from baseline in ALT levels

    Time frame: Up to Week 96

    Change from baseline ALT levels over time during treatment.

  13. Change from baseline in liver stiffness

    Time frame: Up to Week 96

    Change from baseline in liver stiffness as determined by transient elastography at weeks 24, 48 and 96

  14. Change from baseline in APRI

    Time frame: Up to Week 96

    Change from baseline in APRI at weeks 24, 48 and 96.

  15. Change from baseline in CTP score

    Time frame: Up to Week 96

    Change from baseline in CTP score at Weeks 24, 48, and 96 in participants with cirrhosis

  16. Change from baseline in MELD score

    Time frame: Up to Week 96

    Change from baseline in MELD score at Weeks 24, 48, and 96 in participants with cirrhosis

  17. Proportion of participants with clinical disease progression from baseline

    Time frame: Up to Week 96

    Proportion of participants with clinical disease progression from baseline in HDV-associated liver disease at Weeks 24, 48, and 96.

  18. Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up

    Time frame: Up to Week 48

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Mirum

CONTACT

[email protected]

+16506674085

Medinfo Mirum

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mirum Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Mar 6, 2026
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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