NCT00080236

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2003

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

2.2 years

First QC Date

March 24, 2004

Last Update Submit

August 8, 2012

Conditions

Liver TransplantationHepatitisCholestasisCarcinoma, Hepatocellular

Keywords

Liver Transplantation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Donor organ placebo and Recipient placebo

PLACEBO COMPARATOR
Drug: Placebo

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

ACTIVE COMPARATOR
Drug: IDN-6556Drug: Placebo

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

ACTIVE COMPARATOR
Drug: IDN-6556

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

ACTIVE COMPARATOR
Drug: IDN-6556

Interventions

IDN-6556DRUG
Donor organ: IDN-6556 (15μg/ml), Recipient: PlaceboDonor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kgDonor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg
PlaceboDRUG
Donor organ placebo and Recipient placeboDonor organ: IDN-6556 (15μg/ml), Recipient: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum adult age

You may not qualify if:

  • Fulminant hepatic failure (UNOS Status I patients)
  • Previous liver transplantation
  • Patients undergoing split liver grafts
  • Extrahepatic malignancy
  • If female, pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Mayo Clinic Scottsdale

Phoenix, Arizona, 85054, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Baylor Regional Transplant Institute, Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

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

Berlin, D-13353, Germany

Location

Klinik für Viszeral- und Transplantationschirurgie Medizinische Hochschule Hannover

Hanover, D-30623, Germany

Location

Abteilung für Transplantationschirurgie Johannes Gutenberg-Universität Mainz

Mainz, 55101, Germany

Location

MeSH Terms

Conditions

HepatitisCholestasisCarcinoma, Hepatocellular

Interventions

3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBile Duct DiseasesBiliary Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2004

First Posted

March 26, 2004

Study Start

November 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

US(10)DE(3)