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)

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

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.

Conditions2

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