Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency — ELAD  

Chronic Hepatitis Clinical Trial

Official title: Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) in Patients With Acute on Chronic Hepatitis (AOCH)

Status Completed

Clinical Trial Summary

Evaluate on how well the ELAD system works in treating people with liver failure.

Clinical Trial Description

This is a multicenter, open-label, randomized, concurrent control study of subjects with acute on chronic hepatitis. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical therapy for acute liver failure plus the ELAD system, or standard medical therapy alone, with the latter defined as conventional therapy for acute on chronic hepatitis determined to be clinically appropriate by the treating physician.

Immediately prior to treatment initiation, subject eligibility will be confirmed. Treatment with ELAD will continue for a minimum of 3 days and up to a maximum of 10 days or until clinical status improves relative to study entry. Subjects will be followed until 30 days has elapsed since study enrollment (control) or 30 days has elapsed since cessation of ELAD therapy (ELAD group), whichever comes first. ;

Study Design

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

Related Conditions & MeSH terms

• Acute Hepatitis
• Chronic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Chronic

• NCT number: NCT00771446
• Study type: Interventional
• Source: Vital Therapies, Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2008
• Completion date: April 2009