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

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.

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Key information

Conditions

Liver Transplantation Adenocarcinoma Bile Duct Diseases Biliary Tract Diseases Carcinoma Carcinoma, Hepatocellular Cholestasis Digestive System Diseases Digestive System Neoplasms Hepatitis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow, Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IDN-6556

Drug

Placebo

Drug

Primary outcomes

Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation

Sponsors and collaborators

Lead sponsor

Conatus Pharmaceuticals Inc.

Industry

Collaborators

Idun Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2006
First posted: Mar 26, 2004
Registry last updated: Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed