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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure

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.

Detailed Summary: 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.
Sponsor: Vital Therapies, Inc.

Current Primary Outcome: Number of subjects reaching 30-Day survival [ Time Frame: Study Day 30 ]

Original Primary Outcome:

Current Secondary Outcome: 30-day transplant-free survival [ Time Frame: Study Day 30 ]

Original Secondary Outcome:

Information By: Vital Therapies, Inc.

Dates:
Date Received: February 11, 2002
Date Started: January 2002
Date Completion:
Last Updated: July 24, 2012
Last Verified: July 2012