Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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

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

Keywords

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

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 accepting new patients
    San Francisco California 94143 United States
  • Investigative Site accepting new patients
    Vancouver 2C7 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vir Biotechnology, Inc.
ID
NCT04856085
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 415 study participants
Last Updated