Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080236
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2004-03-24
Brief Title:
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Sponsor:
Conatus Pharmaceuticals Inc
Organization:
Conatus Pharmaceuticals Inc
Study Overview
Official Title:
Safety Tolerability and Efficacy Study of a Caspase Inhibitor IDN-6556 in Patients Undergoing Orthotopic Liver Transplantation OLT
Status:
COMPLETED
Status Verified Date:
2012-08
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:
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period
Detailed Description:
The occurrence of apoptosis in liver ischemiareperfusion injury has been well characterized in animal models In this context apoptosis has specifically been observed in sinusoidal endothelial cells and hepatocytes and this has also been associated with an increase in activated caspase-3 in liver tissue extracts The use of caspase inhibitors to prevent apoptosis during liver storage and transplantation may reduce ischemiareperfusion injury and hence improve graft function after transplantation Suppression of apoptosis by caspase inhibitors may also allow for longer ischemic times allowing organs to be transported greater distances In addition suppression of apoptosis may lower the risk involved in using suboptimal donor organs
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