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

Tracking Information

First Received Date ^ICMJE

February 11, 2002

Last Updated Date

October 16, 2009

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00030225 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Fulminant Hepatic Failure

Intervention ^ICMJE

Device: Extracorporeal Liver Assist Device

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Exclusion Criteria:

No evidence of chronic liver disease.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00030225

Responsible Party

Study ID Numbers ^ICMJE

CR-202

Study Sponsor ^ICMJE

Vital Therapies, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Patrick J Maguire, MD, PhD

VitaGen

Information Provided By

Vital Therapies, Inc.

Verification Date

January 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP