Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216470
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-01-08
Brief Title:
Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection VISION
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase II Investigator-Initiated Study to Understand the Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The objective of this study is to evaluate the vaccinal effect of VIR-3434 in chronic HBeAg-negative hepatitis B CHB patients suppressed on nucleostide 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None