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Clinical Trial: Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Fulminant Hepatic Failure | Device: Extracorporeal Liver Assist Device | Phase II |
MedlinePlus related topics: Liver Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Expected Total Enrollment: 18
Study start: January 2002; Expected completion: September 2002
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 - 50 Years, Genders Eligible for Study: Both
Criteria
Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy.
Exclusion Criteria: No evidence of chronic liver disease.
Location and Contact Information
Patrick J Maguire, MD, PhD 858-552-1522 Ext. 105 pmaguire@vgen.com
California
UCSD, San Diego, California, 92103, United States; Recruiting
Marquis Hart, MD, Principal Investigator
Florida
University of Miami, Miami, Florida, 33136, United States; Recruiting
Guy W Neff, MD, Principal Investigator
Georgia
Emory School of Medicine, Atlanta, Georgia, 30322, United States; Recruiting
Thomas Heffron, MD, Principal Investigator
Illinois
University of Chicago, Chicago, Illinois, 60637, United States; Recruiting
Michael Millis, MD, Principal Investigator
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States; Recruiting
Winifred Williams, MD, Principal Investigator
Pennsylvania
University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Peter Linden, MD, Principal Investigator
Virginia
University of Virginia, Charlottesville, Virginia, 22908, United States; Recruiting
Stephen Caldwell, MD, Principal Investigator
Patrick J Maguire, MD, PhD, Study Chair, 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.
Record last reviewed: January 2002
Last Updated: October 13, 2004
Record first received: February 11, 2002
ClinicalTrials.gov Identifier: NCT00030225
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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