Status:
ACTIVE_NOT_RECRUITING
Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection
Lead Sponsor:
Vir Biotechnology, Inc.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy
Eligibility Criteria
Inclusion
- Male or female ages 18 - \<66 years
- Chronic HBV infection for \>/= 6 months
- On NRTI therapy for \>/= 2 months at the time of screening
Exclusion
- Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
- Significant fibrosis or cirrhosis
- History or evidence of drug or alcohol abuse
- History of chronic liver disease from any cause other than chronic HBV infection
- History of hepatic decompensation
- History of anaphylaxis
- History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
- History of immune complex disease
- History of known contraindication to any interferon product
Key Trial Info
Start Date :
July 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04856085
Start Date
July 11 2021
End Date
March 1 2026
Last Update
October 21 2025
Active Locations (37)
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1
Investigative Site
San Francisco, California, United States, 94143
2
Investigative Site
Miami, Florida, United States, 33136
3
Investigative Site
Orlando, Florida, United States, 32803
4
Investigative Site
Baltimore, Maryland, United States, 21218