Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection (MARCH)
Hepatitis B, Chronic
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
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Arms of the Study
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Arm 2
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Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1a (VIR-2218 + VIR-3434)
Cohort 2a (VIR-2218 + VIR-3434)
Cohort 3a (VIR-2218 + VIR-3434)
Cohort 4a (VIR-2218 + VIR-3434)
Cohort 5a (VIR-2218 + VIR-3434)
Cohort 6a (VIR-2218 + VIR-3434)
Cohort 7a (VIR-2218 + VIR-3434)
Cohort 8a (VIR-2218 + VIR-3434)
Cohort 1b (VIR-3434)
Cohort 2b (VIR-3434)
Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)
Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)
Cohort 1d (VIR-2218 + PEG-IFNα)
Cohort 2d (VIR-3434 + PEG-IFNα)
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks
Participants will receive multiple doses of VIR-3434 for 44 weeks
Participants will receive multiple doses of VIR-3434 for 20 weeks
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks
Participants will receive multiple doses of VIR-2218 + PEG-IFNα for 48 weeks
Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks