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

July 24, 2012 updated by: Vital Therapies, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ELAD
Treatment with ELAD, extracorporeal liver assist system and standard of care
Biological: ELAD
Other Names:
  • Extracorporeal Liver Assist Device
OTHER: Standard of care (Control)
Standard of care for patients with fulminant hepatic (liver) failure
Other: Standard of care (Control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects reaching 30-Day survival
Time Frame: Study Day 30
30-day survival
Study Day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day transplant-free survival
Time Frame: Study Day 30
Study Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vital Therapies, Inc.

Investigators

  • Study Chair: Patrick J Maguire, MD, PhD, VitaGen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

February 1, 2003

Study Completion (ACTUAL)

February 1, 2003

Study Registration Dates

First Submitted

February 11, 2002

First Submitted That Met QC Criteria

February 11, 2002

First Posted (ESTIMATE)

February 12, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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