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

Primary Purpose

Liver Transplantation, Hepatitis, Cholestasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IDN-6556
Placebo
Sponsored by
Conatus Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplantation focused on measuring Liver Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Scottsdale
  • University of California Los Angeles
  • University of California San Francisco
  • Indiana University Medical Center
  • Tulane University Hospital and Clinic
  • Mayo Clinic Rochester
  • Mount Sinai School of Medicine
  • University of Cincinnati
  • Baylor Regional Transplant Institute, Baylor University Medical Center
  • The University of Texas Health Science Center at San Antonio
  • Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow
  • Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover
  • Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Donor organ placebo and Recipient placebo

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

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

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 24, 2004
Last Updated
August 8, 2012
Sponsor
Conatus Pharmaceuticals Inc.
Collaborators
Idun Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00080236
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Conatus Pharmaceuticals Inc.
Collaborators
Idun Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Hepatitis, Cholestasis, Carcinoma, Hepatocellular
Keywords
Liver Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Donor organ placebo and Recipient placebo
Arm Type
Placebo Comparator
Arm Title
Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo
Arm Type
Active Comparator
Arm Title
Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg
Arm Type
Active Comparator
Arm Title
Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IDN-6556
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
Title
Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York City
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Baylor Regional Transplant Institute, Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Oberarzt der Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Charité-Virchow
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30623
Country
Germany
Facility Name
Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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