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

This study has been completed.

First Received: February 11, 2002 Last Updated: October 16, 2009 History of Changes

Sponsor:	Vital Therapies, Inc.
Information provided by:	Vital Therapies, Inc.
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

Further study details as provided by Vital Therapies, Inc.:

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

Locations

United States, California
UCSD
San Diego, California, United States, 92103
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory School of Medicine
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

Vital Therapies, Inc.

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
Study First Received:	February 11, 2002
Last Updated:	October 16, 2009
ClinicalTrials.gov Identifier:	NCT00030225 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vital Therapies, Inc.:

Fulminant Hepatic Failure

Additional relevant MeSH terms:

Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute
Hepatic Insufficiency

ClinicalTrials.gov processed this record on November 27, 2009