To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure



Status:Terminated
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:April 2014
End Date:September 2018

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A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD® in Subjects With Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure

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).

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 Day 7 of steroid treatment. The Lille score used in this protocol is being used
independent of steroid administration during the 7 days of evaluation. A Lille score >0.45
(Lille score failure) indicates that the subject is at substantially increased risk of 30-
and 90-day mortality. Subjects with severe acute alcoholic hepatitis (sAAH) are often treated
with steroids as soon as their diagnosis is confirmed. This study is to assess treatment with
the ELAD System in subjects who have failed per the Lille criteria, independent of steroid
administration. ELAD treatment is done continuously for up to 10 days in addition to standard
of care treatment. The Control group (those randomized not to receive ELAD treatment) will
also get standard of care treatment. Standard of care is defined as the usual care for diet,
medications, treatment of complications that may arise, etc. for sAAH patients.

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
We found this trial at
22
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Atlanta, Georgia 30309
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
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Bethesda, Maryland 20814
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
University of Miami Hospital The University of Miami changed the face of modern health care...
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Newark, New Jersey 07103
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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San Diego, California 92093
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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3800 Reservoir Rd NW
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