Study of VIR-2218 + VIR-3434 in Subjects With Chronic Hepatitis B Virus Infection

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    120
  • sponsor
    Vir Biotechnology, Inc.
Updated on 22 September 2021

Summary

This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218+ VIR-3434 and will be assessed for safety, tolerability, and efficacy

Details
Condition chronic hepatitis b
Treatment VIR-2218, VIR-3434
Clinical Study IdentifierNCT04856085
SponsorVir Biotechnology, Inc.
Last Modified on22 September 2021

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 to monoclonal antibodies or antibody fragments
History of immune complex disease
Active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis Delta virus (HDV)
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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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