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

Fulminant Hepatic Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fulminant Hepatic Failure
• Liver Failure
• Liver Failure, Acute

• NCT number: NCT00030225
• Study type: Interventional
• Source: Vital Therapies, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: January 2002
• Completion date: February 2003