Status:
TERMINATED
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
Lead Sponsor:
Vital Therapies, Inc.
Conditions:
Severe Acute Alcoholic Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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).
Detailed Description
The Lille score will be used to identify subjects with an increased risk of mortality (Lille score failures). The Lille score is a prognostic model combining six reproducible variables at Day 0 and Da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01829347
Start Date
April 1 2014
End Date
September 1 2018
Last Update
February 19 2019
Active Locations (39)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
University of California San Diego
San Diego, California, United States, 92103
3
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
4
University of Miami Hospital
Miami, Florida, United States, 33136