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Monoclonal Antibodies

VIR-3434 for Chronic Hepatitis B

Phase 2
Recruiting
Led By Jordan Feld, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 to ≤60 years
Female subjects must have a negative pregnancy test or confirmation of postmenopausal status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through study completion, an average of 2 year
Awards & highlights

Study Summary

This trial is testing an experimental drug called VIR-3434 to see if it can clear the HBsAg, a protein related to hepatitis B virus, from the body. The study will last for

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since specific side effects are not provided here, generally speaking, experimental drugs like VIR-3434 could potentially cause immune reactions, injection site discomfort, fatigue or flu-like symptoms among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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I am not pregnant or I am postmenopausal.
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I agree not to donate eggs or undergo IVF during the study.
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I am a male and will use effective birth control during the study.
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I agree not to donate sperm during the study.
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I have been on stable antiviral therapy for over a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through study completion, an average of 2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through study completion, an average of 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in log Quantitative HBsAg
Secondary outcome measures
Absolute and change of HBV core-related Ag
Absolute and change of Hepatitis B Virus (HBV) RNA
Frequency of AEs and SAEs due to hepatic FNA
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: VIR-3434Experimental Treatment1 Intervention
VIR-3434 300 mg subcutaneous injection every 4 weeks*48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIR-3434
2020
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,402 Total Patients Enrolled
Jordan Feld, MDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
920 Total Patients Enrolled
~10 spots leftby Dec 2029
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