Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis

Inclusion Criteria: * Age \>/= 18\</= 67 years; AND * Acute decompensation of chronic liver disease over the preceding 30 days; AND * MELD score between 18 and 35, inclusive; AND * Subject or designated representative must provide Informed Consent Exclusion Criteria: * Platelets \<50,000mm at baseline; OR * Evidence of chronic renal failure as defined by a serum creatinine \>/= 2.5mg/dL as measured during the 1-6 month period prior to study entry. (Subject is not excluded with a creatinine \>2.5 mg/dL if deemed to be type-1 hepato-renal syndrome); OR * Contraindication to renal replacement therapy (hemodialysis or hemofiltration); OR * International Normalization Ratio (INR) \> 3.5; OR * Septic shock as defined by a positive blood culture and two or more of the following: * Systolic blood pressure \<90mmHg OR mean arterial pressure \<60mmHg; * Tachypnea \> 20 breaths per minute OR a PaCO2\<32 mmHg; * White blood cell count \< 4000 cell/mm3 OR \> 12000 cell/mm3 (\<4 x 10(9) or \>12 x 10(9) cells/L). * Evidence of major hemorrhage as indicated by: * requiring \>/= 4 units packed red blood cells within a 48 hour period prior to Screening, OR * hemodynamic instability (sustained pulse \> 120 beats/min AND systolic blood pressure \< 100 mmHg over one hour) Subjects with a recent history of gastrointestinal hemorrhage who have been successfully treated and remain hemodynamically stable for a period of 48 hours will then be eligible for the study if the investigator determines the subject to be at low risk for rebleeding; OR * Evidence (by physical exam, history or lab evaluation) of significant concomitant disease including chronic congestive heart failure, vascular disease, emphysema, AIDS, hepatitis due to herpes virus, Wilson's disease, or Budd-Chiari syndrome; OR * Known history of hepatocellular carcinoma beyond the Milan criteria and/or portal vein thrombosis; OR * Evidence of spontaneous bacterial peritonitis with uncontrolled infection; OR * Evidence of brain death as determined by blood flow studies positive for herniation AND/OR absence of pupillary reflex; OR * Systolic blood pressure \<85 mmHg OR MAP \<50mmHg at baseline; OR * Requirement for escalating doses of vasopressor support OR of an alpha-adrenergic agent for one hour or longer AND evidence of hemodynamic instability; OR * Subject at maximum vasopressor dose at Screen; OR * Clinical or radiographic evidence of a new stroke or intracerebral bleeding; OR * Seizures uncontrolled by medication; OR * Acute myocardial infarction based on clinical and/or electrocardiographic evidence; OR * Lung disease defined by a PaO2\<60mmHg on room air, acute respiratory distress syndrome, or a history of severe COPD or interstitial lung disease; OR * Pregnancy as determined by beta-HCG results or lactation; OR * Participation in another investigational drug, biologic, or device study within 1 month of enrollment. Subjects enrolled in an observational study will be eligible for this trial. * Previous liver transplant. * Previous participation in a clinical trial involving ELAD.