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

Fulminant Hepatic Failure Clinical Trial

Official title:

Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030225
• Other study ID #: CR-202
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2002
• Last updated: July 24, 2012
• Start date: January 2002
• Est. completion date: February 2003

Study information

• Verified date: July 2012
• Source: Vital Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria:

• Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy

• Weight not less than 40 kilograms

• Not listed for organ transplant, but no medical contraindications for transplant

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

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• ELAD

Other:
• Standard of care (Control)

Locations

Country	Name	City	State
United States	Emory School of Medicine	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	University of Miami	Miami	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	UCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Vital Therapies, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Millis M, Maguire P, Cronin D, Conjeevarum H, Johnson R, Conlin C, Brotherton J, O'Laughlin R, Triglia D, Piazza R: Continuous Human Liver Support As A Bridge To Transplantation. Hepatology- Vol.30, No.4 October 1999 p168A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reaching 30-Day survival	30-day survival	Study Day 30	Yes
Secondary	30-day transplant-free survival		Study Day 30	Yes