Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection (MARCH)

  • STATUS
    Recruiting
  • End date
    Jun 26, 2027
  • participants needed
    260
  • sponsor
    Vir Biotechnology, Inc.
Updated on 26 July 2022

Summary

This is a phase 2 study in which subjects 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

Description

Subjects may be enrolled into cohorts 1a, 2a, 3a, 4a, 5a, 6a, 1b, 2b in a non-randomized manner. Subjects may also be randomized randomized 3:2:2 into cohorts 7a, 8a, or 1c respectively.

Details
Condition Hepatitis B, Chronic
Treatment VIR-2218, VIR-3434, Peg-IFNα
Clinical Study IdentifierNCT04856085
SponsorVir Biotechnology, Inc.
Last Modified on26 July 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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