NCT00080236

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Conatus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Liver Transplantation
• Hepatitis
• Cholestasis
• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	IDN-6556
DRUG	Placebo

Timeline

• Start date: 2003-11-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2004-03-26
• Last updated: 2012-08-10

Locations

13 sites across 2 countries: United States, Germany