Overview
This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
Description
Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 to one of the following treatment arms:
Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Arm 2: Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.
Eligibility
Key Inclusion Criteria:
- Willing and able to provide written informed consent
- Chronic HDV infection
- HDV RNA >500 IU/mL at Screening
- ALT >ULN at Screening
- Willing to take or already taking HBV neucleos(t)ide therapy.
Key Exclusion Criteria:
- Pregnant or nursing females
- Unwilling to comply with contraception requirements during the study
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- Solid organ or bone marrow transplantation
- Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
Note - Other protocol-defined Inclusion/Exclusion criteria apply.