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Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)

Phase 2
18 Years
Not Enrolling
Liver Transplantation, Hepatitis, Cholestasis, Carcinoma, Hepatocellular

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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:


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


United States: Food and Drug Administration

Study ID:




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



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