Spots Global Cancer Trial Database for Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
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Trial Identification
Brief Title: Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Official Title: Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
Study ID: NCT00080236
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Scottsdale, Phoenix, Arizona, United States
University of California Los Angeles, Los Angeles, California, United States
University of California San Francisco, San Francisco, California, United States
Indiana University Medical Center, Indianapolis, Indiana, United States
Tulane University Hospital and Clinic, New Orleans, Louisiana, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Mount Sinai School of Medicine, New York City, New York, United States
University of Cincinnati, Cincinnati, Ohio, United States
Baylor Regional Transplant Institute, Baylor University Medical Center, Dallas, Texas, United States
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow, Berlin, , Germany
Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover, Hannover, , Germany
Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Contact Details
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