The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing additional survival data up to a maximum of 5 years that will be included, as available, through VTI-208 study termination (after the last surviving enrolled subject completes Study Day 91). Secondary objectives are to determine the proportion of survivors at Study Days 28 and 91. Exploratory objectives are to evaluate the ability of ELAD to stabilize liver function, measured using the Model for End Stage Liver Disease (MELD)-based time to progression (TTP) up to Study Day 91, and the proportion of progression-free survivors (PFS) up to Study Days 28 and 91. Progression is defined as death or the first observed increase of at least 5 points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to both End of Study Days 28 and 91 following Randomization.
Subjects randomized to the ELAD® group will receive treatment with ELAD® for a maximum of five (5) 24 hour periods as well as standard of care treatment. Subjects randomized to the Control group will receive standard of care treatment throughout the study. The ITT population includes all randomized subjects assigned to the group to which they were randomized, irrespective of actual treatment administered. Participant, Baseline Characteristics, and Outcome Measures used the ITT population. The safety population is defined as all subjects who are randomized based on actual treatment received. All serious adverse events and all non-serious adverse events analyses used the safety population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
203
ELAD treatment consists of treatment with an extracorporeal liver assist system.
Control receives standard medical treatment.
Maricopa Integrated Health System (MIHS)
Phoenix, Arizona, United States
University of Arizona Medical Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sharp Coronado Hospital
Coronado, California, United States
Keck Hospital of University of Southern California
Los Angeles, California, United States
Overall Survival
The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTI-208E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (31 July 2015).
Time frame: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (31 July 2015)
Number of Survivors at Study Day 91.
Assess the proportion of survivors at Study Day 91.
Time frame: Up to Study Day 91.
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford School of Medicine/Stanford University Medical Center
Palo Alto, California, United States
University of California San Diego Medical Center - Hillcrest
San Diego, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami Hospital
Miami, Florida, United States
...and 35 more locations