Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure - Full Text View

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

U.S. FDA Resources

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
First Received:	February 11, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00030225
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

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	VitaGen
Information provided by:	VitaGen
ClinicalTrials.gov Identifier:	NCT00030225