Switching from bulevirtide to brelovitug for chronic hepatitis D treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2b/3 randomized, open-label, multicenter trial enrolls adults with chronic hepatitis D who have been on bulevirtide for at least six months and have detectable HDV RNA. Eligible participants must remain on a stable HBV antiviral (TDF, TAF, or ETV) and have HDV RNA ≥100 IU/mL at screening. Participants are randomized to switch to brelovitug (BJT-778) or continue current therapy, with regular monitoring of HDV RNA, liver function, and safety events. Key exclusions include decompensated liver disease, prior hepatocellular carcinoma, active HCV or HIV co-infection, immune-complex disease, and other significant liver disorders.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Male or female, ≥18 years of age at Screening.
3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
4. Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
5. HDV RNA ≥100 IU/mL at Screening.

Exclusion Criteria:

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

Where it's running

• Medical University of Graz
  Graz, Austria Recruiting
• Medizinische Universitat Innsbruck
  Innsbruck, Austria Recruiting
• University Hospital St. Polten- Lilenfeld
  Lilienfeld, Austria Recruiting
• Medical University of Vienna
  Vienna, Austria Recruiting
• Fakultni Nemocnice Brno (University Hospital Brno)
  Brno, Czechia Recruiting
• Klin Med Ltd. (KLIN MED s.r.o.)
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: Clinical Trials Mirum
• Email: clinicaltrials@mirumpharma.com
• Phone: +16506674085

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.