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.
The objective of this study is to evaluate the vaccinal effect of VIR-3434 in chronic HBeAg-negative hepatitis B (CHB) patients suppressed on nucleos(t)ide analogue therapy. Total 15 patients will be enrolled at single site. The participants will receive VIR-3434 300 mg subcutaneous injection every 4 weeks x 48 weeks and then follow up for 48 weeks. Total three Fine-needle aspiration (FNA) procedure will be performed during the study: before treatment, 3 days after the first injection and 3 days after the week24 injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
VIR-3434 is a human monoclonal antibody that binds the antigenic loop present in all forms of the surface envelope protein (small, middle, and large HBsAg).
University Health Network
Toronto, Ontario, Canada
RECRUITINGChange in log Quantitative HBsAg
Time frame: from baseline through study completion, an average of 2 year
Absolute and change of Hepatitis B Virus (HBV) RNA
Time frame: from baseline through study completion, an average of 2 year
Absolute and change of HBV core-related Ag
Time frame: from baseline through study completion, an average of 2 year
Proportion of subjects with HBsAg loss
Time frame: from baseline through study completion, an average of 2 year
HBeAg seroconversion
Proportion of subject with HBeAg seroconversion
Time frame: from baseline through study completion, an average of 2 year
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) with study treatment
Frequency of AEs and SAEs with VIR-3434 administration in combination with NA therapy for CHB
Time frame: from baseline through study completion, an average of 2 year
Frequency of AEs and SAEs due to hepatic FNA
Time frame: from baseline through study completion, an average of 2 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.