Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation - Tabular View

Tracking Information
First Received Date ^ICMJE	March 24, 2004
Last Updated Date	June 23, 2005
Start Date ^ICMJE	November 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00080236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Official Title ^ICMJE	Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
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 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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Liver Transplantation Hepatitis Cholestasis Carcinoma, Hepatocellular
Intervention ^ICMJE	Drug: IDN-6556
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	100
Completion Date	December 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Germany

Administrative Information
NCT ID ^ICMJE	NCT00080236
Responsible Party
Study ID Numbers ^ICMJE	CL-000006556-PRO-0006
Study Sponsor ^ICMJE	Idun Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Idun Pharmaceuticals
Verification Date	January 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP