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Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation



Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation

For Condition: Liver Transplantation,Hepatitis,Cholestasis,Carcinoma, Hepatocellular
Status: Recruiting
Sponsor(s): Idun Pharmaceuticals ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 100

Location and Contact Information:

Indiana University Medical Center *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Gail  McNulty 317-278-8822

Tulane University Hospital and Clinic *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Sarah  Foster 504-988-3312

The University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Cyndi  Tourtellot 210-567-9229

Mayo Clinic Scottsdale *Recruiting*
Phoenix,  Arizona,  85054
United States
Recruiting Tina  Bambury 480-342-2543

Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow *Recruiting*
Berlin,  ,  D-13353
Germany
Recruiting Inge  Uhl

Mayo Clinic Rochester *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Sharleen  Cartney 507-266-8493

University of Cincinnati *Recruiting*
Cincinnati,  Ohio,  45267
United States
Recruiting Mike  Alonzo 513-584-0985

Baylor Regional Transplant Institute, Baylor University Medical Center *Recruiting*
Dallas,  Texas,  75246
United States
Recruiting Diane  Johnson 214-820-7260


Additional Information:
Study ID Numbers:
  CL-000006556-PRO-0006; 
Study Start Date: November 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080236

Other Liver Transplantation Studies:
1. A phase II multicenter uncontrolled trial of BAY 43-9006 in patients with advanced hepatocellular carcinoma

2. Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation

3. Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads vs. IV Doxorubicin in Treating Liver Cancer

4. A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure

5. Testing of ADI-PEG in Hepatocellular Carcinoma

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