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

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

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.

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.

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