Study of VIR-2218, VIR-3434, And/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection

Last updated: November 18, 2024
Sponsor: Vir Biotechnology, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

PEG-IFNα

VIR-3434

VIR-2218

Clinical Study ID

NCT04856085
VIR-2218-1006
  • Ages 18-65
  • All Genders

Study 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

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

Exclusion Criteria:

  • Any clinically significant chronic or acute medical condition that makes theparticipant 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 monoclonalantibodies, antibody fragments, or any excipients of VIR-3434

  • History of immune complex disease

  • History of known contraindication to any interferon product

Study Design

Total Participants: 244
Treatment Group(s): 3
Primary Treatment: PEG-IFNα
Phase: 2
Study Start date:
July 11, 2021
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Investigative Site

    Toronto, 2C4
    Canada

    Site Not Available

  • Investigative Site

    Vancouver, 2C7
    Canada

    Site Not Available

  • Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Investigative Site

    Hannover, 30625
    Germany

    Site Not Available

  • Investigative Site

    Mannheim, 68167
    Germany

    Site Not Available

  • Investigative Site

    Ulm, 89081
    Germany

    Site Not Available

  • Investigative Site

    Hong Kong, Tai Po
    Hong Kong

    Site Not Available

  • Investigative Site

    Busan, 49421
    Korea, Republic of

    Site Not Available

  • Investigative Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Investigative Site

    Yangsan, 50612
    Korea, Republic of

    Site Not Available

  • Investigative Site

    Batu Caves, 68100
    Malaysia

    Site Not Available

  • Investigative Site

    Kajang, 43000
    Malaysia

    Site Not Available

  • Investigative Site

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Investigative Site

    Chisinau, MD 2025
    Moldova, Republic of

    Site Not Available

  • Investigative Site

    Auckland, 2025
    New Zealand

    Site Not Available

  • Investigative Site

    Hamilton, 3204
    New Zealand

    Site Not Available

  • Investigative Site

    Tauranga, 3110
    New Zealand

    Site Not Available

  • Investigative Site

    Wellington, 6021
    New Zealand

    Site Not Available

  • Investigative Site

    Bucharest, 021105
    Romania

    Site Not Available

  • Investigative Site

    Chiayi City, 60041
    Taiwan

    Site Not Available

  • Investigative Site

    Kaohsiung City, 83301
    Taiwan

    Site Not Available

  • Investigative Site

    Taichung City, 40705
    Taiwan

    Site Not Available

  • Investigative Site

    Taipei City, 100
    Taiwan

    Site Not Available

  • Investigative Site

    Taoyuan City, 33305
    Taiwan

    Site Not Available

  • Investigative Site

    Kyiv, 01135
    Ukraine

    Site Not Available

  • Investigative Site

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Investigative Site

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Investigative Site

    Manchester, M8 5RB
    United Kingdom

    Site Not Available

  • Investigative Site

    San Francisco, California 94143
    United States

    Site Not Available

  • Investigative Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Investigative Site

    Orlando, Florida 32803
    United States

    Site Not Available

  • Investigative Site

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • Investigative Site

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

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