To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
Stopped early · Phase 3
Conditions studied: Severe Acute Alcoholic Hepatitis
In brief
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).
Key facts
- Study ID
- NCT01829347
- Run by
- Vital Therapies, Inc.
- People needed
- 18
- Starts
- 2014-04-01
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2019-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- University of California San Diego — San Diego, California, United States
- Georgetown University Hospital — Washington D.C., District of Columbia, United States
- University of Miami Hospital — Miami, Florida, United States
- Cleveland Clinic Florida — Weston, Florida, United States
- Piedmont Atlanta Hospital — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Johns Hopkins University Hospital — Bethesda, Maryland, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- University of Minnesota Medical Center - Twin Cities Campus — Minneapolis, Minnesota, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Rutgers University Hospital — Newark, New Jersey, United States
- North Shore University Hospital — Manhasset, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Carolinas Medical Center — Charlotte, North Carolina, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
- Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
- University of Texas Health Science Center, San Antonio — San Antonio, Texas, United States
- Swedish Medical Center — Seattle, Washington, United States
- Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
- Charité Campus Virchow-Klinikum Medizinische Klinik — Berlin, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
- Hospital Clinico Universitario de Santiago de Compostela — Santiago de Compostela, La Coruña, Spain
- Hospital Universitario Puerta de Hierro - Majadahonda — Majadahonda, Madrid, Spain
Full record on ClinicalTrials.gov
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