NCT00030225

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Vital Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Fulminant Hepatic Failure

Interventions

Type	Name	Description
BIOLOGICAL	ELAD
OTHER	Standard of care (Control)

Timeline

• Start date: 2002-01-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2002-02-12
• Last updated: 2012-07-26

Locations

7 sites across 1 country: United States