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.
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 …
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