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

NCT ID: NCT00080236

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Liver Transplantation Hepatitis Cholestasis Carcinoma, Hepatocellular

Keywords

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Donor organ placebo and Recipient placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo

Group Type ACTIVE_COMPARATOR

IDN-6556

Intervention Type DRUG

Placebo

Intervention Type DRUG

Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg

Group Type ACTIVE_COMPARATOR

IDN-6556

Intervention Type DRUG

Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg

Group Type ACTIVE_COMPARATOR

IDN-6556

Intervention Type DRUG

Interventions

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IDN-6556

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Idun Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Conatus Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic Scottsdale

Phoenix, Arizona, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Indiana University Medical Center

Indianapolis, Indiana, United States

Site Status

Tulane University Hospital and Clinic

New Orleans, Louisiana, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Baylor Regional Transplant Institute, Baylor University Medical Center

Dallas, Texas, United States

Site Status

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

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

Berlin, , Germany

Site Status

Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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CL-000006556-PRO-0006

Identifier Type: -

Identifier Source: org_study_id