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| Name | Class |
|---|---|
| Idun Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDN-6556 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation | ||
| Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Phoenix | Arizona | 85054 | United States | ||
| University of California Los Angeles |
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| Placebo | Drug |
|
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Baylor Regional Transplant Institute, Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow | Berlin | D-13353 | Germany |
| Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover | Hanover | D-30623 | Germany |
| Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz | Mainz | 55101 | Germany |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D002779 | Cholestasis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C487112 | 3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid |
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