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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 | |
| Study Chair: | Patrick J Maguire, MD, PhD | VitaGen |
More Information
| 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 |
|
Fulminant Hepatic Failure |
|
Liver Failure Liver Diseases Digestive System Diseases Liver Failure, Acute Hepatic Insufficiency |
|
Liver Failure Liver Diseases Digestive System Diseases Liver Failure, Acute Hepatic Insufficiency |
