To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
Severe Acute Alcoholic Hepatitis
About this trial
This is an interventional treatment trial for Severe Acute Alcoholic Hepatitis focused on measuring liver failure, acute alcoholic hepatitis, patients failing steroid therapy, alcoholic hepatitis, steroid failure, Lille criteria, ELAD
Eligibility Criteria
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 clinical evidence indicates liver size of <10 cm or volume of <750 cc is not considered reduced for the individual subject;
- Chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome);
- Uncontrolled seizures;
- Positive serologies for viral hepatitis B or C;
- Pregnancy as determined by β-human chorionic gonadotropin (HCG) results;
- Participation in another investigational drug, biologic, or device study within one month of enrollment, except for observational studies (the observational study setting should not affect the safety and/or efficacy of the VTI-210 clinical trial);
- Currently listed or scheduled for liver transplant during the 90-day study period;
- Previous liver transplant;
- Previous participation in a clinical trial involving ELAD;
- Has a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or local equivalent) or any other Advanced Directive limiting Standard of Care in place (the DNR/DNI criterion is not applicable in the UK);
- Refusal to participate in the VTI-210E follow-up study;
- Is unable to provide an address for follow-up home visits.
And other inclusion/exclusion criteria
Sites / Locations
- University of Arkansas for Medical Sciences
- University of California San Diego
- Georgetown University Hospital
- University of Miami Hospital
- Cleveland Clinic Florida
- Piedmont Atlanta Hospital
- Emory University Hospital
- Johns Hopkins University Hospital
- Beth Israel Deaconess Medical Center
- University of Minnesota Medical Center - Twin Cities Campus
- University of Nebraska Medical Center
- Rutgers University Hospital
- Montefiore Medical Center
- North Shore University Hospital
- Carolinas Medical Center
- Cleveland Clinic Foundation
- Drexel University College of Medicine
- Albert Einstein Medical Center
- University of Texas Health Science Center, San Antonio
- Swedish Medical Center
- Aurora St. Luke's Medical Center
- Charité Campus Virchow-Klinikum Medizinische Klinik
- Medizinische Hochschule Hannover
- Hospital Clinico Universitario de Santiago de Compostela
- Hospital Universitario Puerta de Hierro - Majadahonda
- Hospital Universitario de Cruces
- Hospital Clinic de Barcelona
- Hospital Reina Sofia
- Hospital Gregorio Marañon
- Hospital Universitario Ramón y Cajal
- Hospital Universitario Marques de Valdecilla
- Hospital Universitario de Valme
- Hospital Universitario y Politécnico La Fe
- Barts Health NHS Trust
- King's College Hospital NHS Foundation Trust
- Royal Free Hospital
- NHS Tayside
- Doncaster Royal Infirmary
- Brighton & Sussex University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Other
ELAD (plus Standard of Care)
Standard of Care (Control)
ELAD is a human cell-based bio-artificial liver support system developed to improve survival of patients with acute liver failure and to provide liver support continuously to a subject with compromised liver function. Standard of care is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
Standard of care is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.