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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMirum Pharmaceuticals, Inc.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Brelovitug (BJT-778)
  • Bulevirtide

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators