Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

• Status: Active, not recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brii Biosciences Limited
• Collaborator: Vir Biotechnology, Inc.
• Treatments: Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• Male or female aged 18-60.

• Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.

• Chronic HBV infection for ≥ 6 months.

• On NRTI therapy for at least 6 months.

Exclusion Criteria:

• Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.

• Significant liver fibrosis or cirrhosis.

• History or evidence of drug or alcohol abuse.

• History of intolerance to SC injection.

• History of chronic liver disease from any cause other than chronic HBV infection.

• History of hepatic decompensation.

• Contraindications to the use of Peg-IFNα.