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

August 8, 2012 updated by: Conatus Pharmaceuticals Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, D-13353
        • Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow
      • Hannover, Germany, D-30623
        • Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover
      • Mainz, Germany, 55101
        • Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Scottsdale
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Hospital and Clinic
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New York
      • New York City, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Regional Transplant Institute, Baylor University Medical Center
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Donor organ placebo and Recipient placebo
Drug: Placebo
Active Comparator: Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo
Drug: Placebo
Drug: IDN-6556
Active Comparator: Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg
Drug: IDN-6556
Active Comparator: Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg
Drug: IDN-6556

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Conatus Pharmaceuticals Inc.

Collaborators

Idun Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

March 24, 2004

First Submitted That Met QC Criteria

March 25, 2004

First Posted (Estimate)

March 26, 2004

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 8, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-000006556-PRO-0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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