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

Completed · Phase 2

Conditions studied: Fulminant Hepatic Failure

In brief

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.

Key facts

Study ID

NCT00030225

Run by

Vital Therapies, Inc.

People needed

19

Starts

2002-01-01

Expected to finish

2003-02-01

Last updated by the study team

2012-07-26

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSD — San Diego, California, United States
• University of Miami — Miami, Florida, United States
• Emory School of Medicine — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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