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

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Brief Title

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)

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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


Condition

Liver Transplantation

Intervention

IDN-6556

Study Arms / Comparison Groups

 Donor organ placebo and Recipient placebo
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

99

Start Date

November 2003

Completion Date

January 2006

Primary Completion Date

January 2006

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00080236

Organization ID

CL-000006556-PRO-0006


Responsible Party

Sponsor

Study Sponsor

Conatus Pharmaceuticals Inc.

Collaborators

 Idun Pharmaceuticals

Study Sponsor

, , 


Verification Date

August 2012