RECRUITINGPhase 2INTERVENTIONAL

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)

A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BIOLOGICAL

BRII-179

BRII-179 will be given via intramuscular injection

DRUG

BRII-835 (VIR-2218)

BRII-835 will be given via subcutaneous injection

BIOLOGICAL

PEG-IFNα

PEG-IFNα will be given via subcutaneous injection

DRUG

Placebo of BRII-179

Placebo of BRII-179 will be given via intramuscular injection

DRUG