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)

Phase 2 Recruiting 250 enrolled Brii Biosciences Limited

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2024-10-31
Primary completion: 2026-07
Completion: 2027-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BRII-179	Vaccine	—	Intramuscular
Subject	BRII-835	Unknown	—	Subcutaneous
Background	Peginterferon alfa-2a	Protein / enzyme biologic	—	Subcutaneous

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

Timeline

Drugs

Indications