~10 spots leftby Dec 2029

VIR-3434 for Hepatitis B

JF
Overseen byJordan Feld, MD, MPH
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University Health Network, Toronto
Must be taking: Nucleos(t)ide therapy
Must not be taking: Peginterferon, Immunosuppressives
Disqualifiers: Cirrhosis, Hepatocellular carcinoma, HIV, others
No Placebo Group
Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection. The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body. This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it requires that you have been on stable nucleos(t)ide therapy for more than a year.

Research Team

JF

Jordan Feld, MD, MPH

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals with chronic hepatitis B. Participants will be involved in the study for about 104 weeks, receiving VIR-3434 weekly for the first 48 weeks and then being followed up for another 48 weeks.

Inclusion Criteria

Quantitative HBsAg 500 - 10,000 IU/mL
I am not pregnant, breastfeeding, and agree to use effective birth control during the study.
I am between 18 and 60 years old.
See 10 more

Exclusion Criteria

estimated Glomerular Filtration Rate (eGFR) < 45 cc/min
Bilirubin > 40 µmol/L
I have a history of severe liver disease.
See 20 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VIR-3434 300 mg subcutaneous injection every 4 weeks for 48 weeks

48 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks
12 visits (in-person)

Treatment Details

Interventions

  • VIR-3434 (Monoclonal Antibodies)
Trial OverviewThe trial is testing VIR-3434, an experimental drug aimed at targeting and clearing the HBsAg of hepatitis B virus from the body. It's a Phase II study where all participants receive the actual medication without any placebo.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: VIR-3434Experimental Treatment1 Intervention
VIR-3434 300 mg subcutaneous injection every 4 weeks\*48 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+
Dr. Brad Wouters profile image

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith profile image

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto