NCT06491563

Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

A Phase 2 Multicenter, Open-label Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and Pegylated Interferon Alpha (PEG-IFNα) for the Treatment of Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Brii Biosciences Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Conditions

• For Treatment of Chronic Hepatitis B Virus 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

Timeline

• Start date: 2024-08-06
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-07-09
• Last updated: 2024-12-30

Locations

12 sites across 1 country: China

Regulatory

• FDA-regulated drug study