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

NCT07454837 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-25

No results posted yet for this study

Summary

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).

Conditions

  • Chronic Hepatitis D

Interventions

DRUG

Brelovitug (BJT-778)

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

DRUG

Bulevirtide

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

Sponsors & Collaborators

  • Mirum Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-26
Primary Completion
2027-08-31
Completion
2029-03-30
FDA Drug
Yes

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Italy
  • Romania
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07454837 on ClinicalTrials.gov