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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01829347
Recruitment Status : Terminated (Due to results from the VTI-208 study, the ELAD plan is being re-evaluated.)
First Posted : April 11, 2013
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Information provided by (Responsible Party):
Vital Therapies, Inc.

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).

Condition or disease Intervention/treatment Phase
Severe Acute Alcoholic Hepatitis Biological: ELAD Other: Standard of Care treatment Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ELAD (plus Standard of Care)
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.
Biological: ELAD
ELAD is an extracorporeal system that draws blood from the subject via a dual-lumen catheter placed in a large vein, and then separates the plasma fluid (ultrafiltrate) from cellular components using a specifically-designed ultrafiltrate generator cartridge. While the cellular components are returned to the subject via the venous access, the ultrafiltrate is circulated at a high flow rate through the four metabolically-active ELAD cartridges which contain cloned, immortalized human hepatoblastoma cells (VTL C3A cells) derived from a subclone of the human hepatoblastoma cell line HepG2.
Other Name: Human Cell-Based Bio-Artificial Liver Support System

Other: Standard of Care treatment
Standard of care treatment is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
Other Name: Usual treatment for the disease

Standard of Care (Control)
Standard of care is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
Other: Standard of Care treatment
Standard of care treatment is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
Other Name: Usual treatment for the disease

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data at the time of database lock (11 July 2016), approximately 27 months ]
    The primary endpoint of the study was a comparison of overall survival (OS) between ELAD-treated and Control groups, with protocol VTI-210E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (11 July 2016).

Secondary Outcome Measures :
  1. Proportion of Survivors at Study Day 91. [ Time Frame: Up to Study Day 91. ]
    Assess the proportion of survivors at Study Day 91.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01829347

Show Show 39 study locations
Sponsors and Collaborators
Vital Therapies, Inc.
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Study Director: Jan Stange, MD Vital Therapies, Inc.
Principal Investigator: Rajiv Jalan, MD UK - Royal Free Hospital
Principal Investigator: Juan Caballeria, MD Spain - Hospital Clinic de Barcelona
Principal Investigator: José Luis Montero, MD Spain - Hospital Reina Sofia
Principal Investigator: Rafael Bañares, MD Spain - Hospital Gregorio Marañon
Principal Investigator: Kalyan R Bhamidimarri, MD FL - University of Miami Hospital
Principal Investigator: Julie Thompson, MD MN - University of Minnesota Medical Center - Twin Cities Campus
Principal Investigator: Valentin Cuervas-Mons Martinez, MD Spain - Hospital Universitario Puerta de Hierro - Majadahonda
Principal Investigator: Santiago Tome, MD Spain - Hospital Clinico Universitario de Santiago de Compostela
Principal Investigator: Martín Prieto, MD Spain - Hospital Universitario y Politécnico La Fe
Principal Investigator: Sumita Verma, MD UK - Brighton & Sussex University Hospitals NHS Trust
Principal Investigator: Paul J Gaglio, MD NY - Montefiore Medical Center
Principal Investigator: Manuel Romero-Gomez, MD Spain - Hospital Universitario de Valme
Principal Investigator: Andrew deLemos, MD NC - Carolinas Medical Center
Principal Investigator: Joanna Sayer, MD UK - Doncaster Royal Infirmary
Principal Investigator: Lance Stein, MD GA - Piedmont Atlanta Hospital
Principal Investigator: Javier Crespo, MD Spain - Hospital Universitario Marques de Valdecilla
Principal Investigator: Rohit Satoskar, MD DC - Georgetown University Hospital
Principal Investigator: David J Kramer, MD WI - Aurora St. Luke's Medical Center
Principal Investigator: David Reich, MD PA - Drexel University College of Medicine
Principal Investigator: Anne M Larson, MD WA - Swedish Medical Center
Principal Investigator: Xaralambos Zervos, DO FL - Cleveland Clinic Florida
Principal Investigator: Kirti Shetty, MD MD - Johns Hopkins University Hospital
Principal Investigator: Simona Rossi, MD PA - Albert Einstein Medical Center
Principal Investigator: Ram Subramanian, MD GA - Emory University Hospital
Principal Investigator: Alexander Kuo, MD CA - University of California San Diego
Principal Investigator: Talal Adhami, MD OH - Cleveland Clinic Foundation
Principal Investigator: Maria Jesús Suárez, MD Spain - Hospital Universitario de Cruces
Principal Investigator: Nikolaos T Pyrsopoulos, MD NJ - Rutgers University Hospital
Principal Investigator: Julio Gutierrez, MD TX - University of Texas Health Science Center, San Antonio
Principal Investigator: Andres Duarte-Rojo, MD AR - University of Arkansas for Medical Sciences
Principal Investigator: Agustín Albillos, MD Spain - Hospital Universitario Ramón y Cajal
Principal Investigator: Raza Malik, MD MA - Beth Israel Deaconess Medical Center
Principal Investigator: Markus Busch, MD Germany - Medizinische Hochschule Hannover
Principal Investigator: Anupama Duddempudi, MD NY - North Shore University Hospital
Principal Investigator: Marco Antonio Olivera-Martinez, MD NE - University of Nebraska Medical Center
Principal Investigator: Eckart Schott, MD Germany - Charité Campus Virchow-Klinikum Medizinische Klinik
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vital Therapies, Inc. Identifier: NCT01829347    
Other Study ID Numbers: VTI-210
First Posted: April 11, 2013    Key Record Dates
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019
Last Verified: February 2019
Keywords provided by Vital Therapies, Inc.:
liver failure
acute alcoholic hepatitis
patients failing steroid therapy
alcoholic hepatitis
steroid failure
Lille criteria
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders