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| 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 |
| Estimated Enrollment: | 18 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | 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 to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy.
Exclusion Criteria:
No evidence of chronic liver disease.
Contacts and Locations| Contact: Brian Dickson, MD | dickson@covalentgroup.com | |
| Contact: Patrick J Maguire, MD, PhD | 858-552-1522 ext 105 | pmaguire@vgen.com |
| 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 | |||||
| VitaGen |
| Study Chair: | Patrick J Maguire, MD, PhD | VitaGen |
More Information
|
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.
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| 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 |
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