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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030225
Recruitment Status : Completed
First Posted : February 12, 2002
Last Update Posted : July 26, 2012
Information provided by (Responsible Party):
Vital Therapies, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Fulminant Hepatic Failure Biological: ELAD Other: Standard of care (Control) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure
Study Start Date : January 2002
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003

Arm Intervention/treatment
Experimental: ELAD
Treatment with ELAD, extracorporeal liver assist system and standard of care
Biological: ELAD
Other Name: Extracorporeal Liver Assist Device

Standard of care (Control)
Standard of care for patients with fulminant hepatic (liver) failure
Other: Standard of care (Control)

Primary Outcome Measures :
  1. Number of subjects reaching 30-Day survival [ Time Frame: Study Day 30 ]
    30-day survival

Secondary Outcome Measures :
  1. 30-day transplant-free survival [ Time Frame: Study Day 30 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy
  • Weight not less than 40 kilograms
  • Not listed for organ transplant, but no medical contraindications for transplant

Exclusion Criteria:

  • Listed for organ transplant at stud entry
  • History of jaundice for greater than 28 days at screening
  • Liver dysfunction due to trauma
  • Concomitant serious disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030225

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United States, California
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.
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Study Chair: Patrick J Maguire, MD, PhD VitaGen

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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Responsible Party: Vital Therapies, Inc. Identifier: NCT00030225    
Other Study ID Numbers: CR-202
First Posted: February 12, 2002    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012
Keywords provided by Vital Therapies, Inc.:
Fulminant Hepatic Failure
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases
Liver Extracts