To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
Launched by VITAL THERAPIES, INC. · Apr 10, 2013
Trial Information
Current as of May 20, 2025
Terminated
Keywords
ClinConnect Summary
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 i...
Gender
ALL
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
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biopharmaceutical company dedicated to developing innovative cell-based therapies for the treatment of acute liver failure and other serious liver diseases. Focused on advancing its proprietary ELAD® (Extracorporeal Liver Assist Device) system, the company aims to provide a bridge to transplant for patients suffering from liver dysfunction. With a commitment to improving patient outcomes through rigorous clinical research and development, Vital Therapies leverages cutting-edge technology and scientific expertise to address critical unmet medical needs in hepatology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Bronx, New York, United States
Boston, Massachusetts, United States
Hannover, , Germany
Manhasset, New York, United States
Little Rock, Arkansas, United States
Bronx, New York, United States
Philadelphia, Pennsylvania, United States
Barcelona, , Spain
Santander, , Spain
San Diego, California, United States
Omaha, Nebraska, United States
Seattle, Washington, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Washington, District Of Columbia, United States
Philadelphia, Pennsylvania, United States
Madrid, , Spain
Sevilla, , Spain
Cordoba, , Spain
Milwaukee, Wisconsin, United States
Santiago De Compostela, La Coruña, Spain
London, , United Kingdom
Madrid, , Spain
Miami, Florida, United States
Valencia, , Spain
Newark, New Jersey, United States
Doncaster, South Yorkshire, United Kingdom
Brighton, , United Kingdom
London, , United Kingdom
Charlotte, North Carolina, United States
Bethesda, Maryland, United States
Minneapolis, Minnesota, United States
San Antonio, Texas, United States
Berlin, , Germany
Majadahonda, Madrid, Spain
Baracaldo, Vizcaya, Spain
London, England, United Kingdom
Hampstead, London, United Kingdom
Dundee, Scotland, United Kingdom
Patients applied
Trial Officials
Jan Stange, MD
Study Director
Vital Therapies, Inc.
Rajiv Jalan, MD
Principal Investigator
UK - Royal Free Hospital
Juan Caballeria, MD
Principal Investigator
Spain - Hospital Clinic de Barcelona
José Luis Montero, MD
Principal Investigator
Spain - Hospital Reina Sofia
Rafael Bañares, MD
Principal Investigator
Spain - Hospital Gregorio Marañon
Kalyan R Bhamidimarri, MD
Principal Investigator
FL - University of Miami Hospital
Julie Thompson, MD
Principal Investigator
MN - University of Minnesota Medical Center - Twin Cities Campus
Valentin Cuervas-Mons Martinez, MD
Principal Investigator
Spain - Hospital Universitario Puerta de Hierro - Majadahonda
Santiago Tome, MD
Principal Investigator
Spain - Hospital Clinico Universitario de Santiago de Compostela
Martín Prieto, MD
Principal Investigator
Spain - Hospital Universitario y Politécnico La Fe
Sumita Verma, MD
Principal Investigator
UK - Brighton & Sussex University Hospitals NHS Trust
Paul J Gaglio, MD
Principal Investigator
NY - Montefiore Medical Center
Manuel Romero-Gomez, MD
Principal Investigator
Spain - Hospital Universitario de Valme
Andrew deLemos, MD
Principal Investigator
NC - Carolinas Medical Center
Joanna Sayer, MD
Principal Investigator
UK - Doncaster Royal Infirmary
Lance Stein, MD
Principal Investigator
GA - Piedmont Atlanta Hospital
Javier Crespo, MD
Principal Investigator
Spain - Hospital Universitario Marques de Valdecilla
Rohit Satoskar, MD
Principal Investigator
DC - Georgetown University Hospital
David J Kramer, MD
Principal Investigator
WI - Aurora St. Luke's Medical Center
David Reich, MD
Principal Investigator
PA - Drexel University College of Medicine
Anne M Larson, MD
Principal Investigator
WA - Swedish Medical Center
Xaralambos Zervos, DO
Principal Investigator
FL - Cleveland Clinic Florida
Kirti Shetty, MD
Principal Investigator
MD - Johns Hopkins University Hospital
Simona Rossi, MD
Principal Investigator
PA - Albert Einstein Medical Center
Ram Subramanian, MD
Principal Investigator
GA - Emory University Hospital
Alexander Kuo, MD
Principal Investigator
CA - University of California San Diego
Talal Adhami, MD
Principal Investigator
OH - Cleveland Clinic Foundation
Maria Jesús Suárez, MD
Principal Investigator
Spain - Hospital Universitario de Cruces
Nikolaos T Pyrsopoulos, MD
Principal Investigator
NJ - Rutgers University Hospital
Julio Gutierrez, MD
Principal Investigator
TX - University of Texas Health Science Center, San Antonio
Andres Duarte-Rojo, MD
Principal Investigator
AR - University of Arkansas for Medical Sciences
Agustín Albillos, MD
Principal Investigator
Spain - Hospital Universitario Ramón y Cajal
Raza Malik, MD
Principal Investigator
MA - Beth Israel Deaconess Medical Center
Markus Busch, MD
Principal Investigator
Germany - Medizinische Hochschule Hannover
Anupama Duddempudi, MD
Principal Investigator
NY - North Shore University Hospital
Marco Antonio Olivera-Martinez, MD
Principal Investigator
NE - University of Nebraska Medical Center
Eckart Schott, MD
Principal Investigator
Germany - Charité Campus Virchow-Klinikum Medizinische Klinik
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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