drugset / Trial / NCT06216470

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

NCT06216470

Phase 2 Recruiting 15 enrolled University Health Network, Toronto
NaSingle-groupOpen-labelTreatment

Summary

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 receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.

Timeline

Start
2024-03-13
Primary completion
2029-12
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tobevibart Monoclonal antibody 300 mg Subcutaneous