Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure
1 other identifier
interventional
19
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2002
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 11, 2002
CompletedFirst Posted
Study publicly available on registry
February 12, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedJuly 26, 2012
July 1, 2012
1.1 years
February 11, 2002
July 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects reaching 30-Day survival
30-day survival
Study Day 30
Secondary Outcomes (1)
30-day transplant-free survival
Study Day 30
Study Arms (2)
ELAD
EXPERIMENTALTreatment with ELAD, extracorporeal liver assist system and standard of care
Standard of care (Control)
OTHERStandard of care for patients with fulminant hepatic (liver) failure
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
UCSD
San Diego, California, 92103, United States
University of Miami
Miami, Florida, 33136, United States
Emory School of Medicine
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Related 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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Patrick J Maguire, MD, PhD
VitaGen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2002
First Posted
February 12, 2002
Study Start
January 1, 2002
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
July 26, 2012
Record last verified: 2012-07