VIR-3434 for Hepatitis B

Recruiting in Palo Alto (17 mi)

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.

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.

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Exclusion Criteria

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

Bilirubin > 40 µmol/L

I have a history of severe liver disease.

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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