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Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure



Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure

For Condition: Fulminant Hepatic Failure
Status: Recruiting
Sponsor(s): VitaGen ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy. Exclusion Criteria: No evidence of chronic liver disease.
Total Enrollment: 18

Location and Contact Information:

Overall Study Official:
PatrickMaguire,  Study Chair,  VitaGen

University of Miami *Recruiting*
Miami,  Florida,  33136
United States
Recruiting Guy  Neff 305-355-5160

Massachusetts General Hospital *Recruiting*
Boston,  Massachusetts,  02114
United States
Recruiting Winifred  Williams 617-724-3833

University of Virginia *Recruiting*
Charlottesville,  Virginia,  22908
United States
Recruiting Stephen  Caldwell 434-924-2626

University of Chicago *Recruiting*
Chicago,  Illinois,  60637
United States
Recruiting Michael  Millis 773-702-6319

UCSD *Recruiting*
San Diego,  California,  92103
United States
Recruiting Marquis  Hart 619-543-5870

University of Pittsburgh *Recruiting*
Pittsburgh,  Pennsylvania,  15213
United States
Recruiting Peter  Linden 412-647-7899

Emory School of Medicine *Recruiting*
Atlanta,  Georgia,  30322
United States
Recruiting Thomas  Heffron 404-727-3599


Additional Information:
Study ID Numbers:
  CR-202; 
Study Start Date: January 2002
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030225

Other Fulminant Hepatic Failure Studies:
1. Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure

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