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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through study completion, an average of 2 year

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,165 Total Patients Enrolled

Jordan Feld, MDPrincipal InvestigatorUniversity Health Network, Toronto

2 Previous Clinical Trials

920 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this clinical trial?

"To be eligible for enrollment in this clinical trial, potential participants must have a confirmed diagnosis of chronic hepatitis b. Additionally, they should fall within the age range of 18 to 60 years old. The study has limited availability and will only accept a total of 15 qualified candidates."

Answered by AI

Are potential participants currently able to apply for this ongoing medical study?

"According to the information provided on clinicaltrials.gov, this trial is not currently accepting new participants. The original posting date was 2/1/2024 and the last update occurred on 1/19/2024. However, it's worth noting that there are currently 238 other studies actively recruiting volunteers."

Answered by AI

Is the study currently accepting participants below the age of 60?

"The target population for this clinical trial consists of individuals between 18 and 60 years old."

Answered by AI

Has the FDA granted approval for the utilization of VIR-3434 in medical treatment?

"Due to the nature of this being a Phase 2 trial, there is some preliminary data indicating safety for VIR-3434. However, no efficacy data has been established at this point. Therefore, our team rates its safety as a 2 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]

2024. "Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216470.

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