Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure

Inclusion Criteria:

• Age ≥ 18 years;
• Total bilirubin ≥ 8 mg/dL;
• A clinical diagnosis of alcohol-induced liver decompensation (AILD), based upon evidence (by lab test, medical history, or family interview) of a clinical judgment of a temporal (6 weeks or less) and causal relationship between use of alcohol and this onset of symptoms;

• Subjects will be classified as having either:

  a. Severe acute alcoholic hepatitis (AAH), with: i. Medical history of alcohol abuse; AND ii. Maddrey score of ≥ 32; AND iii. AAH documented by either:

  1. Confirmatory liver biopsy; OR 2. Two or more of the following:

  1. Hepatomegaly,
  2. AST > ALT,
  3. Ascites,
  4. Leukocytosis (WBC count above lab normal at site), OR

  b. Alcohol-induced decompensation of chronic liver disease that is not acute alcoholic hepatitis (as defined above), with: i. MELD score of 18-35; AND ii. Underlying chronic liver disease documented by:

  1. Liver biopsy, AND/OR
  2. Laboratory findings, AND/OR
  3. Medical history;
• Not eligible for liver transplant during this hospitalization;
• Subject or designated representative must provide Informed Consent;
• Subject must be eligible for Standard of Care treatment as defined in the protocol.

Exclusion Criteria:

• Platelet count < 40,000/mm3;
• International Normalization Ratio (INR) > 3.5;
• MELD Score > 35;
• AST > 500 IU/L;
• Evidence of infection unresponsive to antibiotics;
• Evidence of reduction in total bilirubin of 20% or more in the previous 72 hours, if available:
• Evidence of hemodynamic instability
• Evidence of active bleeding or of major hemorrhage occurring within 48 hours of Screening;
• Clinical evidence of liver size reduction due to cirrhosis ;
• 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;
• Subject has chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome);
• Subject has liver disease related to homozygous hemachromatosis, Wilson's Disease, has non-alcoholic fatty liver disease, or Budd-Chiari Syndrome;
• Pregnancy as determined by β-human chorionic gonadotropin (HCG) results, or lactation;
• Participation in another investigational drug, biologic, or device study within one month of enrollment, except for observational studies;
• Previous liver transplant;
• Previous participation in a clinical trial involving ELAD;
• Have a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or such local equivalent) or any other Advanced Directive limiting Standard of Care in place;
• Inability to provide an address for followup home health visits.