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

Recruiting Phase 2 Interventional Study
Hepatitis B, Chronic
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
University Health Network, Toronto · Other
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About 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 rec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 to ≤65 years 2. Chronic HBV infection with evidence of HBsAg-positivity x \> 6 months 3. Quantitative HBsAg 300 - 10,000 IU/mL 4. On stable nucleos(t)ide therapy \>1 year 5. HBV DNA \< 60 IU/mL on 2 occasions at least 12 weeks apart 6. ALT ≤ 45 U/L on 2 occasions at …
Contacts

Jordan Feld, MD

416-340-4584

jordan.feld@uhn.ca

CONTACT

Jiayun Chen

416-340-4800

jiayun.chen@uhn.ca

CONTACT