Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-… (NCT01471028) | Clinical Trial Compass
CompletedPhase 3
Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
United States203 participantsStarted 2013-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Hepatomegaly,
✓. AST \> ALT,
✓. Ascites,
✓. Leukocytosis (WBC count above lab normal at site), OR
✓. Liver biopsy, AND/OR
✓. Laboratory findings, AND/OR
✓. Medical history;
Exclusion criteria
✕. Systolic blood pressure \< 90 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
✕. Mean arterial pressure (MAP) \< 60 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
✕. Requirement for escalating doses of vasopressor support prior to Screening; OR
✕. Subject at maximum vasopressor dose at Screening;
What they're measuring
1
Overall Survival
Timeframe: 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)