VIR-3434 for Hepatitis B

Overseen By Jiayun Chen

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 48 weeks

15 Participants Needed

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

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 not pregnant or I am postmenopausal.

Exclusion Criteria

estimated Glomerular Filtration Rate (eGFR) < 45 cc/min

Bilirubin > 40 µmol/L

I have a history of severe liver disease.

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

Trial Overview The 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

Group I: VIR-3434 Experimental Treatment 1 Intervention

VIR-3434 300 mg subcutaneous injection every 4 weeks\*48 weeks

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+