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

NCT ID: NCT00030225

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-02-28

Brief Summary

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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

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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.

Conditions

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Fulminant Hepatic Failure

Keywords

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Fulminant Hepatic Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ELAD

Treatment with ELAD, extracorporeal liver assist system and standard of care

Group Type EXPERIMENTAL

ELAD

Intervention Type BIOLOGICAL

Standard of care (Control)

Standard of care for patients with fulminant hepatic (liver) failure

Group Type OTHER

Standard of care (Control)

Intervention Type OTHER

Interventions

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ELAD

Intervention Type BIOLOGICAL

Standard of care (Control)

Intervention Type OTHER

Other Intervention Names

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Extracorporeal Liver Assist Device

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vital Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick J Maguire, MD, PhD

Role: STUDY_CHAIR

VitaGen

Locations

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UCSD

San Diego, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Emory School of Medicine

Atlanta, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

Other Identifiers

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CR-202

Identifier Type: -

Identifier Source: org_study_id