Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
18 Years
N/A
Both
Liver Transplantation, Hepatitis, Cholestasis, Carcinoma, Hepatocellular
Trial Information
Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
Authority:
United States: Food and Drug Administration
Study ID:
CL-000006556-PRO-0006
NCT ID:
NCT00080236
Start Date:
November 2003
Completion Date:
January 2006
Related Keywords:
- Liver Transplantation
- Hepatitis
- Cholestasis
- Carcinoma, Hepatocellular
- Liver Transplantation
- Carcinoma
- Cholestasis
- Hepatitis
- Hepatitis A
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| University of California Los Angeles | Los Angeles, California 90095-6951 |
| University of California San Francisco | San Francisco, California 941104206 |
| Indiana University Medical Center | Indianapolis, Indiana 46202 |
| Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Mayo Clinic Rochester | Rochester, Minnesota 55905 |
| Baylor Regional Transplant Institute, Baylor University Medical Center | Dallas, Texas 75246 |
| The University of Texas Health Science Center at San Antonio | San Antonio, Texas 78229 |
