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Monoclonal Antibodies

VIR-3434 for 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
Must not have
History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) > 12 kilopascals (kPa), liver biopsy (F4 by METAVIR) or clinical evidence of decompensation (ascites, hepatic encephalopathy)
History of or current hepatocellular carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through study completion, an average of 2 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of severe liver disease.
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I have or had liver cancer.
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I am co-infected with HIV.
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I have a chronic liver condition, but it's not hepatitis B or just fatty liver.
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I have been on strong immune system suppressing drugs recently.
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I don't have major health issues that could affect this study.
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I have had a liver or other solid organ transplant.
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I have a significant liver condition such as alcoholic liver disease or autoimmune hepatitis.
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I am unable to understand and agree to the study's procedures and risks.
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I have a blood disorder like thalassemia or sickle cell disease.
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I have not taken any experimental drugs or vaccines within the last 90 days or longer, depending on the drug.
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I am on blood thinners or have a bleeding disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) with study treatment
HBeAg seroconversion

Side effects data

From 2022 Phase 1 trial • 113 Patients • NCT04423393
33%
Nausea
17%
Dizziness
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: Healthy Participants 3000 mg IV
Part B: HBV Participants 300 mg SC
Part C: HBV Participants Placebo
Part D: HBV Participants 300 mg SC
Part C: HBV Participants 75 mg SC
Part A Healthy Participants Placebo
Part C: HBV Participants 300 mg SC
Part A: Healthy Participants 90 mg SC
Part A Healthy Participants 300 mg SC
Part D: HBV Participants Placebo
Part B: HBV Participants 18 mg SC
Part B: HBV Participants 6 mg SC
Part A Healthy Participants 900 mg IV
Part C: HBV Participants 18 mg SC
Part D: HBV Participants 75 mg SC
Part A Healthy Participants 900 mg SC
Part B: HBV Participants 75 mg SC
Part B: HBV Participants Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,523 Previous Clinical Trials
503,183 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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