Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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

Official Title

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Details

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

Keywords

Hepatitis B, Chronic, Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis, Hepatitis A, Hepatitis B, Virus Diseases, Herpesviridae Infections, Hepatitis, Chronic, VIR-2218, VIR-3434, PEG-IFNα, VIR-2218 + VIR-3434

Eligibility

You can join if…

Open to people ages 18-65

  • Male or female ages 18 - <66 years
  • Chronic HBV infection for >/= 6 months
  • On NRTI therapy for >/= 2 months at the time of screening

You CAN'T join if...

  • 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

Locations

  • Investigative Site not yet accepting patients
    San Francisco California 94143 United States
  • Investigative Site not yet accepting patients
    Vancouver 2C7 Canada

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Vir Biotechnology, Inc.
ID
NCT04856085
Phase
Phase 2 Hepatitis B Research Study
Study Type
Interventional
Participants
Expecting 260 study participants
Last Updated