NCT00771446

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Vital Therapies, Inc. · Industry
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Acute Hepatitis
• Chronic Hepatitis

Interventions

Type	Name	Description
BIOLOGICAL	ELAD plus standard of care treatment	ELAD is a liver assist system - Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)
OTHER	Standard of care treatment	Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-10-13
• Last updated: 2013-04-12

Locations

6 sites across 1 country: United States