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

Phase 2

Completed

• Conditions: Fulminant Hepatic Failure
• Interventions: Biological: ELAD; Other: Standard of care (Control)

• Registration Number: NCT00030225
• Lead Sponsor: Vital Therapies, Inc.

Brief 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.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2002-02-11
• Study First Submitted QC: 2002-02-11
• Study First Posted: 2002-02-12
• Primary Completion: 2003-02
• Study Completion: 2003-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

• Listed for organ transplant at stud entry
• History of jaundice for greater than 28 days at screening
• Liver dysfunction due to trauma
• Concomitant serious disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELAD	ELAD	Treatment with ELAD, extracorporeal liver assist system and standard of care
Standard of care (Control)	Standard of care (Control)	Standard of care for patients with fulminant hepatic (liver) failure

Primary Outcome Measures

Name	Time	Method
Number of subjects reaching 30-Day survival	Study Day 30	30-day survival

Secondary Outcome Measures

Name	Time	Method
30-day transplant-free survival	Study Day 30

Trial Locations

Locations (7)

University of Miami; 🇺🇸 Miami, Florida, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Emory School of Medicine; 🇺🇸 Atlanta, Georgia, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

UCSD; 🇺🇸 San Diego, California, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States