A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Trial Parameters
Brief Summary
This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.
Eligibility Criteria
Inclusion Criteria: * Male or female aged 18-60 years. * Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * Chronic HBV infection for ≥ 6 months. * On NRTI therapy with HBV DNA \< LLOQ for ≥ 6 months. * Serum ALT and AST ≤ ULN at screening visit. Exclusion Criteria: * Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study. * Significant liver fibrosis or cirrhosis. * History of clinically significant chronic liver disease from any cause other than chronic HBV infection. * History of hepatic decompensation. * Diagnosed or suspected hepatocellular carcinoma. * Current or past history of infection with HIV, HCV or HDV. * Any laboratory test abnormality that may contradict treatment with PEG-IFNα. * Known history of immunological function impairment. * History of intolerance to intramuscular or subcutaneous injection.