Clinical trial NCT00080236: Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Official title: Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Transplantation
Hepatitis
Cholestasis
Carcinoma, Hepatocellular
Keywords: Liver Transplantation
Lead sponsor: Conatus Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: Idun Pharmaceuticals
First posted: 2004-03-26
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
measure: Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York City
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Dallas
country: United States
facility: Baylor Regional Transplant Institute, Baylor University Medical Center
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Berlin
country: Germany
facility: Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow
city: Hannover
country: Germany
facility: Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover
city: Mainz
country: Germany
facility: Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz
Study officials:
References: