RecruitingPhase 2/3

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

Austria, Czechia, France120 participantsStarted 2026-02-26

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: Week 24

Trial details

NCT IDNCT07454837

SponsorMirum Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Clinical Trials Mirum

+16506674085 clinicaltrials@mirumpharma.com

View on ClinicalTrials.gov More Chronic Hepatitis D trials