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

This study is currently recruiting patients.

Sponsored by: Idun Pharmaceuticals
Information provided by: Idun Pharmaceuticals

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 Treatment or Intervention Phase
Liver Transplantation
Hepatitis
Cholestasis
Carcinoma, Hepatocellular
  Drug: IDN-6556
 Phase II

MedlinePlus related topics:  Bile Duct Diseases;   Hepatitis;   Liver Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  100

Study start: November 2003;  Study completion: September 2004

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 above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information


Arizona
      Mayo Clinic Scottsdale, Phoenix,  Arizona,  85054,  United States; Recruiting
Tina Bambury, RN, MBA  480-342-2543    bambury.tina@mayo.edu 
David Mulligan, MD, PhD,  Principal Investigator

California
      University of California San Francisco, San Francisco,  California,  94143,  United States; Recruiting
Abdel Rahmaoui  415-514-0192    rahmaouia@surgery.ucsf.edu 
Beverly Nikolai, CCRC  415-514-0959    NikolaiB@surgery.ucsf.edu 
Sandy Feng, MD, PhD,  Principal Investigator

Indiana
      Indiana University Medical Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Gail McNulty, RN  317-278-8822    gmcnulty@iupui.edu 
Sharon Henson, LPN  317-278-0040    shenson@clarian.org 
Paul Kwo, MD,  Principal Investigator

Louisiana
      Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
Sarah Foster  504-988-3312    sfoster1@tulane.edu 
Sander Florman, MD,  Principal Investigator

Minnesota
      Mayo Clinic Rochester, Rochester,  Minnesota,  55905,  United States; Recruiting
Sharleen Cartney, RN  507-266-8493    cartney.sharleen@mayo.edu 
Jennie Wilson, RN  507-284-6814    wilson.jennie@mayo.edu 
Gregory Gores, MD,  Principal Investigator

New York
      Mount Sinai School of Medicine, New York City,  New York,  10029,  United States; Suspended

Ohio
      University of Cincinnati, Cincinnati,  Ohio,  45267,  United States; Recruiting
Mike Alonzo, MD  513-584-0985    alonzom@ucmail.uc.edu 
Steven Rudich, MD, PhD,  Principal Investigator

Texas
      Baylor Regional Transplant Institute, Baylor University Medical Center, Dallas,  Texas,  75246,  United States; Recruiting
Diane Johnson, RN, MSN  214-820-7260    dianejoh@baylorhealth.edu 
Goran Klintmalm, MD, PhD,  Principal Investigator

      The University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229,  United States; Recruiting
Cyndi Tourtellot, RN, BSN  210-567-9229    cltourtellot@university-health-sys.com 
W. Kenneth Washburn, MD,  Principal Investigator

Germany
      Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow, Berlin,  D-13353,  Germany; Recruiting
Inge Uhl   inge.uhl@charite.de 
Jochen Klupp, PD Dr. med.,  Principal Investigator

      Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover, Hannover,  D-30623,  Germany; Recruiting
Thomas Becker, Dr. med.  49 511 532 3446    becker.thomas@mh-hannover 
Juergen Klempnauer, Prof. Dr.,  Principal Investigator

      Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz, Mainz,  55101,  Germany; Not yet recruiting
Marcus Schuchmann, Dr. med.  49 613 117-1    schuchm@mail.uni-mainz.de 
Gerd Otto, Prof. Dr. med.,  Principal Investigator

More Information

Study ID Numbers:  CL-000006556-PRO-0006
Record last reviewed:  March 2004
Record first received:  March 24, 2004
ClinicalTrials.gov Identifier:  NCT00080236
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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