Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF) — ELAD  

Fulminant Hepatic Failure Clinical Trial

Official title: Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)

Status Withdrawn

Clinical Trial Summary

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

Clinical Trial Description

Therapy will generally include treatment of hepatic encephalopathy using lactulose with or without oral antibiotics, antibiotics as indicated to treat infection, volume resuscitation and vasopressors as indicated to treat hypotension. In addition general medical treatment such as glucose control and renal replacement therapy will be used as necessary. Subjects with a clinical diagnosis of hepato-renal syndrome may be treated with midodrine and octreotide or terlipressin, if considered appropriate therapy.

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 30 days, until, in the Investigator's opinion, clinical status improves relative to entry; until the subject undergoes OLT; or until the continued use of ELAD® is contraindicated, as described in Section 5.5. Subjects will be followed until discontinuation or 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

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

• NCT number: NCT00832728
• Study type: Interventional
• Source: Vital Therapies, Inc.
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2009
• Completion date: September 2011