Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection
NCT ID: NCT04856085
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
244 participants
INTERVENTIONAL
2021-07-11
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1a (VIR-2218 + VIR-3434)
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 2a (VIR-2218 + VIR-3434)
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 3a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 4a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 5a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 6a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 7a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 8a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 1b (VIR-3434)
Participants will receive multiple doses of VIR-3434 for 44 weeks
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 2b (VIR-3434)
Participants will receive multiple doses of VIR-3434 for 20 weeks
VIR-3434
VIR-3434 given by subcutaneous injection
Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
PEG-IFNα
PEG-IFNα given by subcutaneous injection
Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks
VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
PEG-IFNα
PEG-IFNα given by subcutaneous injection
Cohort 1d (VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks
VIR-3434
VIR-3434 given by subcutaneous injection
PEG-IFNα
PEG-IFNα given by subcutaneous injection
Interventions
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VIR-2218
VIR-2218 given by subcutaneous injection
VIR-3434
VIR-3434 given by subcutaneous injection
PEG-IFNα
PEG-IFNα given by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic HBV infection for \>/= 6 months
* On NRTI therapy for \>/= 2 months at the time of screening
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Vir Biotechnology, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigative Site
San Francisco, California, United States
Investigative Site
Miami, Florida, United States
Investigative Site
Orlando, Florida, United States
Investigative Site
Baltimore, Maryland, United States
Investigative Site
Hillsborough, New Jersey, United States
Investigative Site
Toronto, , Canada
Investigative Site
Toronto, , Canada
Investigative Site
Vancouver, , Canada
Investigative Site
Frankfurt, , Germany
Investigative Site
Hanover, , Germany
Investigative Site
Mannheim, , Germany
Investigative Site
Hong Kong, Shatin, Hong Kong
Investigative Site
Hong Kong, Tai Po District, Hong Kong
Investigative Site
Hong Kong, , Hong Kong
Investigative Site
Kuala Lumpur, , Malaysia
Investigative Site
Chisinau, , Moldova
Investigative Site
Auckland, , New Zealand
Investigative Site
Auckland, , New Zealand
Investigative Site
Hamilton, , New Zealand
Investigative Site
Tauranga, , New Zealand
Investigative Site
Wellington, , New Zealand
Investigative Site
Bucharest, , Romania
Investigative Site
Busan, , South Korea
Investigative Site
Seoul, , South Korea
Investigative Site
Seoul, , South Korea
Investigative Site
Yangsan, , South Korea
Investigative Site
Chiayi City, , Taiwan
Investigative Site
Kaohsiung City, , Taiwan
Investigative Site
Kaohsiung City, , Taiwan
Investigative Site
Taichung, , Taiwan
Investigative Site
Taipei, , Taiwan
Investigative Site
Taoyuan, , Taiwan
Investigative Site
Kyiv, , Ukraine
Investigative Site
Birmingham, , United Kingdom
Investigative Site
London, , United Kingdom
Investigative Site
London, , United Kingdom
Investigative Site
Manchester, , United Kingdom
Countries
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Other Identifiers
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VIR-2218-1006
Identifier Type: -
Identifier Source: org_study_id
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