Trial | NCT00080236  Report issue

Title

Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    emricasan ...

  • Study Participants

    99
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.
The occurrence of apoptosis in liver ischemia/reperfusion 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 ischemia/reperfusion 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 Started
Nov 30
2003
Primary Completion
Jan 31
2006
Study Completion
Jan 31
2006
Last Update
Aug 10
2012
Estimate

Drug IDN-6556

Drug Placebo

Donor organ placebo and Recipient placebo Placebo Comparator

Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo Active Comparator

Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg Active Comparator

Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg Active Comparator

Criteria 

Inclusion Criteria:

Minimum adult age

Exclusion Criteria:

Fulminant hepatic failure (UNOS Status I patients)
Previous liver transplantation
Patients undergoing split liver grafts
Extrahepatic malignancy
If female, pregnant or lactating
No Results Posted