To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lill… (NCT01829347) | Clinical Trial Compass
TerminatedPhase 3
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
Stopped: Due to results from the VTI-208 study, the ELAD plan is being re-evaluated.
United States18 participantsStarted 2014-04
Plain-language summary
The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score \>0.45).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥18 ;
* Total bilirubin ≥8 mg/dL;
* Medical history of alcohol abuse with evidence of a causal and temporal (\<6 weeks) relationship to the use of alcohol and hospital admission for this episode of sAAH;
* Maddrey score ≥32
* A clinical diagnosis of severe acute alcoholic hepatitis (sAAH);
* Subject must have liver biopsy or in investigator's opinion, if risk is too great to perform liver biopsy, then clinical diagnosis is sufficient;
* Subject must be a Lille score failure (Lille score \>0.45) as defined in this study.
Exclusion Criteria:
* Platelet count \<50,000/mm3;
* International Normalization Ratio (INR) \>3.0;
* MELD score \>35;
* Evidence of infection unresponsive to antibiotics;
* Evidence of jaundice for \>3 months;
* Hospital admission for any episodes of liver decompensation not related to sAAH, (other than this episode of sAAH) within the past 2 months;
* Evidence of hemodynamic instability;
* Evidence of active bleeding or of major hemorrhage defined as requiring ≥2 units of packed red blood cells to maintain a stable hemoglobin occurring within 48 hours of Screening;
* Evidence of occlusive portal vein thrombosis impairing hepatopetal flow, or evidence of bile duct obstruction;
* Evidence by physical exam, history, or laboratory evaluation of significant concomitant disease with expected life expectancy of less than 3 months;
* Clinical evidence of liver size reduction due to cirrhosis, unless Investigator interpretation of the cli…
What they're measuring
1
Overall Survival
Timeframe: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data at the time of database lock (11 July 2016), approximately 27 months