Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
Chronic Hepatitis B Virus Infection
About this trial
This is an interventional treatment trial for Chronic Hepatitis B Virus Infection
Eligibility 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.
Sites / Locations
- Investigative Site 61001
- Investigative Site 61002Recruiting
- Investigative Site 61003Recruiting
- Investigative Site 86001
- Investigative Site 85201Recruiting
- Investigative Site 85202Recruiting
- Investigative Site 85203
- Investigative Site 85204
- Investigative Site 88601
- Investigative Site 88602Recruiting
- Investigative Site 88603
- Investigative Site 88604
- Investigative Site 82001Recruiting
- Investigative Site 82002Recruiting
- Investigative Site 82004Recruiting
- Investigative Site 82003
- Investigative Site 60005
- Investigative Site 60001
- Investigative Site 60003
- Investigative Site 60004
- Investigative Site 60002
- Investigative Site 65001
- Investigative Site 65002
- Investigative Site 66003
- Investigative Site 66002
- Investigative Site 66004
- Investigative Site 66005
- Investigative Site 66001
- Investigative Site 66006
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Participants will receive multiple doses of PEG-IFNα for 48 weeks.
Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.