Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
- Conditions
- Fulminant Hepatic Failure
- Registration Number
- NCT00030225
- Lead Sponsor
- Vital Therapies, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of subjects reaching 30-Day survival Study Day 30 30-day survival
- Secondary Outcome Measures
Name Time Method 30-day transplant-free survival Study Day 30
Trial Locations
- Locations (7)
UCSD
🇺🇸San Diego, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Emory School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
UCSD🇺🇸San Diego, California, United States