Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473824
Status:
TERMINATED
Last Update Posted:
2021-07-30
First Post:
2007-05-14
Brief Title:
Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous Human CivacirTM in Liver Transplantation
Sponsor:
ADMA Biologics Inc
Organization:
ADMA Biologics Inc
Study Overview
Official Title:
A Randomized Open-Label Phase II Study to Evaluate the Safety Pharmacokinetics and Efficacy of Hepatitis C Immune Globulin Intravenous Human CivacirTM in Liver Transplant Recipients
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New sponsors decision to pursue a redesigned clinical study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 2 study to evaluate safety pharmacokinetics and efficacy of Hepatitis C Immune Globulin Intravenous human CivacirTM for preventing or reducing the impact of recurrent HCV infection following liver transplantation
Detailed Description:
Hepatitis C virus HCV infection is the leading single cause of liver transplantation LT in the US and Europe Recurrence of HCV infection following LT is almost universal There is currently no effective way to prevent post-transplantation HCV infection of the liver graft and related progression of HCV-related liver disease This study is designed to evaluate a polyclonal human hepatitis C immune globulin Civacir given during and post liver transplantation for preventing or reducing the impact of recurrent HCV infection
In this open-label trial 2 subjects will be randomized to receive Civacir standard of care treatment plus Civacir for every 1 Control subject standard of care treatment alone Civacir recipients will receive 18 intravenous infusions over 24 weeks beginning at the time of liver transplantation
Viral loads liver enzyme assessments and liver biopsy assessments will be made at scheduled intervals during the study which will last for 48 weeks
In this open-label trial 2 subjects will be randomized to receive Civacir standard of care treatment plus Civacir for every 1 Control subject standard of care treatment alone Civacir recipients will receive 18 intravenous infusions over 24 weeks beginning at the time of liver transplantation
Viral loads liver enzyme assessments and liver biopsy assessments will be made at scheduled intervals during the study which will last for 48 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None