Status:
ACTIVE_NOT_RECRUITING
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
Lead Sponsor:
Brii Biosciences Limited
Collaborating Sponsors:
Vir Biotechnology, Inc.
Conditions:
Chronic Hepatitis B Virus Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05970289
Start Date
August 22 2023
End Date
February 1 2026
Last Update
September 5 2025
Active Locations (29)
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1
Investigative Site 61001
Kingswood, New South Wales, Australia, 2747
2
Investigative Site 61002
Birtinya, Queensland, Australia, 4575
3
Investigative Site 61003
Melbourne, Victoria, Australia, 3004
4
Investigative Site 86001
Beijing, Beijing Municipality, China, 100000