NCT06650852

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Brii Biosciences Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B Virus (HBV) Infection

Interventions

Type	Name	Description
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	Placebo of BRII-835	Placebo of BRII-835 will be given via subcutaneous injection

Timeline

• Start date: 2024-10-31
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2024-10-21
• Last updated: 2025-05-23

Locations

14 sites across 1 country: China

Regulatory

• FDA-regulated drug study