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Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
This study is currently recruiting participants.
Verified by VitaGen, January 2002
First Received: February 11, 2002   Last Updated: June 23, 2005   History of Changes
Sponsored by: VitaGen
Information provided by: VitaGen
ClinicalTrials.gov Identifier: NCT00030225
  Purpose

The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.


Condition Intervention Phase
Fulminant Hepatic Failure
Device: Extracorporeal Liver Assist Device
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by VitaGen:

Estimated Enrollment: 18
Study Start Date: January 2002
Estimated Study Completion Date: September 2002
Detailed Description:

Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy.

Exclusion Criteria:

No evidence of chronic liver disease.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030225

Contacts
Contact: Brian Dickson, MD dickson@covalentgroup.com
Contact: Patrick J Maguire, MD, PhD 858-552-1522 ext 105 pmaguire@vgen.com

Locations
United States, California
UCSD Recruiting
San Diego, California, United States, 92103
Contact: Marquis Hart, MD     619-543-5870     mahart@ucsd.edu    
Principal Investigator: Marquis Hart, MD            
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Guy W Neff, MD     305-355-5160     gneff@med.miami.edu    
Principal Investigator: Guy W Neff, MD            
United States, Georgia
Emory School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Thomas Heffron, MD     404-727-3599     Thomas_heffron@emory.org    
Principal Investigator: Thomas Heffron, MD            
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Michael Millis, MD     773-702-6319     mmillis@surgery.bsd.uchicago.edu    
Principal Investigator: Michael Millis, MD            
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Winifred Williams, MD     617-724-3833     wwilliams@partners.org    
Principal Investigator: Winifred Williams, MD            
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Peter Linden, MD     412-647-7899        
Principal Investigator: Peter Linden, MD            
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Stephen Caldwell, MD     434-924-2626     shc5c@virginia.edu    
Principal Investigator: Stephen Caldwell, MD            
Sponsors and Collaborators
VitaGen
Investigators
Study Chair: Patrick J Maguire, MD, PhD VitaGen
  More Information

Publications:
Millis M, Maguire P, Cronin D, Conjeevarum H, Johnson R, Conlin C, Brotherton J, O'Laughlin R, Triglia D, Piazza R: Continuous Human Liver Support As A Bridge To Transplantation. Hepatology- Vol.30, No.4 October 1999 p168A.

Study ID Numbers: CR-202
Study First Received: February 11, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00030225     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by VitaGen:
Fulminant Hepatic Failure

Study placed in the following topic categories:
Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute
Hepatic Insufficiency

Additional relevant MeSH terms:
Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute
Hepatic Insufficiency

ClinicalTrials.gov processed this record on July 02, 2009