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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080236
• Other study ID #: CL-000006556-PRO-0006
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2004
• Last updated: August 8, 2012
• Start date: November 2003
• Est. completion date: January 2006

Study information

• Verified date: August 2012
• Source: Conatus Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholestasis
• Hepatitis
• Liver Transplantation

Intervention

Drug:
• IDN-6556

• Placebo

Locations

Country	Name	City	State
Germany	Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow	Berlin
Germany	Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover	Hannover
Germany	Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz	Mainz
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baylor Regional Transplant Institute, Baylor University Medical Center	Dallas	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	University of California Los Angeles	Los Angeles	California
United States	Tulane University Hospital and Clinic	New Orleans	Louisiana
United States	Mount Sinai School of Medicine	New York City	New York
United States	Mayo Clinic Scottsdale	Phoenix	Arizona
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Conatus Pharmaceuticals Inc.	Idun Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
Primary	Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation