Back to resultsPhase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
Primary Purpose
Fulminant Hepatic Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ELAD
Standard of care (Control)
Sponsored by
About this trial
This is an interventional treatment trial for Fulminant Hepatic Failure focused on measuring Fulminant Hepatic Failure
Eligibility Criteria
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
Sites / Locations
- UCSD
- University of Miami
- Emory School of Medicine
- University of Chicago
- Massachusetts General Hospital
- University of Pittsburgh
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ELAD
Standard of care (Control)
Arm Description
Treatment with ELAD, extracorporeal liver assist system and standard of care
Standard of care for patients with fulminant hepatic (liver) failure
Outcomes
Primary Outcome Measures
Number of subjects reaching 30-Day survival
30-day survival
Secondary Outcome Measures
30-day transplant-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00030225
Brief Title
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
Official Title
Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vital Therapies, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fulminant Hepatic Failure
Keywords
Fulminant Hepatic Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELAD
Arm Type
Experimental
Arm Description
Treatment with ELAD, extracorporeal liver assist system and standard of care
Arm Title
Standard of care (Control)
Arm Type
Other
Arm Description
Standard of care for patients with fulminant hepatic (liver) failure
Intervention Type
Biological
Intervention Name(s)
ELAD
Other Intervention Name(s)
Extracorporeal Liver Assist Device
Intervention Type
Other
Intervention Name(s)
Standard of care (Control)
Primary Outcome Measure Information:
Title
Number of subjects reaching 30-Day survival
Description
30-day survival
Time Frame
Study Day 30
Secondary Outcome Measure Information:
Title
30-day transplant-free survival
Time Frame
Study Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J Maguire, MD, PhD
Organizational Affiliation
VitaGen
Official's Role
Study Chair
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
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Learn more about this trial
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
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