Overview
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).
Description
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).
Eligibility
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.
