Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of E… (NCT02612428) | Clinical Trial Compass
TerminatedPhase 3
Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD
Stopped: VTL-308 failed to meet its primary endpoint, all follow up studies were terminated
United States151 participantsStarted 2016-01
Plain-language summary
The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.
The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a chi-squared test.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion criteria
✓. Age ≥18;
✓. Total bilirubin ≥16 mg/dL (≥273.6 µmol/L);
✓. A clinical diagnosis of alcohol-induced liver decompensation (AILD), based upon lab test or medical history or family interview with a causal relationship and temporal association (6 weeks or less) of alcohol use and hospital admission for this episode of AILD;
✓. Maddrey score ≥32;
✓. Subjects must have AILD that is severe acute alcoholic hepatitis (sAAH) diagnosed with either:
✓. AILD that is sAAH with no underlying liver disease other than alcoholic liver disease, OR
✓. AILD that is sAAH with evidence of underlying liver disease other than alcoholic liver disease which must be documented by:
✓. Not eligible for liver transplant during this hospitalization;
Exclusion criteria
✕. Age ≥50;
What they're measuring
1
Overall Survival
Timeframe: Up to at least Study Day 91, with protocol VTL-308E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (28 August 2018).
✕. Evidence of infection unresponsive to antibiotics (e.g. increased tissue involvement relative to initial diagnosis, clinical worsening of symptoms, etc.) indicated by any of the following: