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| Sponsored by: |
Idun Pharmaceuticals |
|---|---|
| Information provided by: | Idun Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00080236 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Transplantation Hepatitis Cholestasis Carcinoma, Hepatocellular |
Drug: IDN-6556 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT) |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Phoenix, Arizona, United States, 85054 | |
| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| University of California Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| United States, Indiana | |
| Indiana University Medical Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Minnesota | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York City, New York, United States, 10029 | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Texas | |
| Baylor Regional Transplant Institute, Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| The University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Germany | |
| Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz | |
| Mainz, Germany, 55101 | |
| Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30623 | |
| Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow | |
| Berlin, Germany, D-13353 | |
More Information
| Study ID Numbers: | CL-000006556-PRO-0006 |
| Study First Received: | March 24, 2004 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00080236 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Liver Transplantation |
|
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Cholestasis Carcinoma Hepatitis Liver Neoplasms |
Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Liver Diseases Digestive System Neoplasms Neoplasms by Histologic Type Cholestasis Carcinoma, Hepatocellular Carcinoma Hepatitis Liver Neoplasms |
Neoplasms Neoplasms by Site Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
