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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2005 by Idun Pharmaceuticals. Recruitment status was Active, not recruiting

First Received on March 24, 2004. Last Updated on June 23, 2005 History of Changes

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Liver Transplantation

U.S. FDA Resources

Further study details as provided by Idun Pharmaceuticals:

Estimated Enrollment:	100
Study Start Date:	November 2003
Estimated Study Completion Date:	December 2005

Detailed Description:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080236

Locations

United States, Arizona
Mayo Clinic Scottsdale
Phoenix, Arizona, United States, 85054
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
University of California San Francisco
San Francisco, California, United States, 94143
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
Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow
Berlin, Germany, D-13353
Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover
Hannover, Germany, D-30623
Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55101

Sponsors and Collaborators

Idun Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00080236 History of Changes
Other Study ID Numbers:	CL-000006556-PRO-0006
Study First Received:	March 24, 2004
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Idun Pharmaceuticals:

Liver Transplantation

Additional relevant MeSH terms:

Carcinoma
Cholestasis
Hepatitis
Hepatitis A
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

Liver Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 09, 2012