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

Primary Purpose

Severe Acute Alcoholic Hepatitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ELAD
Standard of Care treatment
Sponsored by
Vital Therapies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Alcoholic Hepatitis focused on measuring liver failure, acute alcoholic hepatitis, patients failing steroid therapy, alcoholic hepatitis, steroid failure, Lille criteria, ELAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • University of California San Diego
  • Georgetown University Hospital
  • University of Miami Hospital
  • Cleveland Clinic Florida
  • Piedmont Atlanta Hospital
  • Emory University Hospital
  • Johns Hopkins University Hospital
  • Beth Israel Deaconess Medical Center
  • University of Minnesota Medical Center - Twin Cities Campus
  • University of Nebraska Medical Center
  • Rutgers University Hospital
  • Montefiore Medical Center
  • North Shore University Hospital
  • Carolinas Medical Center
  • Cleveland Clinic Foundation
  • Drexel University College of Medicine
  • Albert Einstein Medical Center
  • University of Texas Health Science Center, San Antonio
  • Swedish Medical Center
  • Aurora St. Luke's Medical Center
  • Charité Campus Virchow-Klinikum Medizinische Klinik
  • Medizinische Hochschule Hannover
  • Hospital Clinico Universitario de Santiago de Compostela
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital Universitario de Cruces
  • Hospital Clinic de Barcelona
  • Hospital Reina Sofia
  • Hospital Gregorio Marañon
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario de Valme
  • Hospital Universitario y Politécnico La Fe
  • Barts Health NHS Trust
  • King's College Hospital NHS Foundation Trust
  • Royal Free Hospital
  • NHS Tayside
  • Doncaster Royal Infirmary
  • Brighton & Sussex University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ELAD (plus Standard of Care)

Standard of Care (Control)

Arm Description

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.

Standard of care is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.

Outcomes

Primary Outcome Measures

Overall Survival
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

Proportion of Survivors at Study Day 91.
Assess the proportion of survivors at Study Day 91.

Full Information

First Posted
April 8, 2013
Last Updated
February 12, 2019
Sponsor
Vital Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01829347
Brief Title
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to results from the VTI-208 study, the ELAD plan is being re-evaluated.
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vital Therapies, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Alcoholic Hepatitis
Keywords
liver failure, acute alcoholic hepatitis, patients failing steroid therapy, alcoholic hepatitis, steroid failure, Lille criteria, ELAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ELAD (plus Standard of Care)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care (Control)
Arm Type
Other
Arm Description
Standard of care is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
Intervention Type
Biological
Intervention Name(s)
ELAD
Other Intervention Name(s)
Human Cell-Based Bio-Artificial Liver Support System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care treatment
Other Intervention Name(s)
Usual treatment for the disease
Intervention Description
Standard of care treatment is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
Primary Outcome Measure Information:
Title
Overall Survival
Description
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).
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
Secondary Outcome Measure Information:
Title
Proportion of Survivors at Study Day 91.
Description
Assess the proportion of survivors at Study Day 91.
Time Frame
Up to Study Day 91.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Stange, MD
Organizational Affiliation
Vital Therapies, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rajiv Jalan, MD
Organizational Affiliation
UK - Royal Free Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Caballeria, MD
Organizational Affiliation
Spain - Hospital Clinic de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Luis Montero, MD
Organizational Affiliation
Spain - Hospital Reina Sofia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafael Bañares, MD
Organizational Affiliation
Spain - Hospital Gregorio Marañon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kalyan R Bhamidimarri, MD
Organizational Affiliation
FL - University of Miami Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie Thompson, MD
Organizational Affiliation
MN - University of Minnesota Medical Center - Twin Cities Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valentin Cuervas-Mons Martinez, MD
Organizational Affiliation
Spain - Hospital Universitario Puerta de Hierro - Majadahonda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Santiago Tome, MD
Organizational Affiliation
Spain - Hospital Clinico Universitario de Santiago de Compostela
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martín Prieto, MD
Organizational Affiliation
Spain - Hospital Universitario y Politécnico La Fe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sumita Verma, MD
Organizational Affiliation
UK - Brighton & Sussex University Hospitals NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul J Gaglio, MD
Organizational Affiliation
NY - Montefiore Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Romero-Gomez, MD
Organizational Affiliation
Spain - Hospital Universitario de Valme
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew deLemos, MD
Organizational Affiliation
NC - Carolinas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanna Sayer, MD
Organizational Affiliation
UK - Doncaster Royal Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lance Stein, MD
Organizational Affiliation
GA - Piedmont Atlanta Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Crespo, MD
Organizational Affiliation
Spain - Hospital Universitario Marques de Valdecilla
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rohit Satoskar, MD
Organizational Affiliation
DC - Georgetown University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David J Kramer, MD
Organizational Affiliation
WI - Aurora St. Luke's Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Reich, MD
Organizational Affiliation
PA - Drexel University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne M Larson, MD
Organizational Affiliation
WA - Swedish Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xaralambos Zervos, DO
Organizational Affiliation
FL - Cleveland Clinic Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirti Shetty, MD
Organizational Affiliation
MD - Johns Hopkins University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simona Rossi, MD
Organizational Affiliation
PA - Albert Einstein Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ram Subramanian, MD
Organizational Affiliation
GA - Emory University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Kuo, MD
Organizational Affiliation
CA - University of California San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Talal Adhami, MD
Organizational Affiliation
OH - Cleveland Clinic Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Jesús Suárez, MD
Organizational Affiliation
Spain - Hospital Universitario de Cruces
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikolaos T Pyrsopoulos, MD
Organizational Affiliation
NJ - Rutgers University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio Gutierrez, MD
Organizational Affiliation
TX - University of Texas Health Science Center, San Antonio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andres Duarte-Rojo, MD
Organizational Affiliation
AR - University of Arkansas for Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agustín Albillos, MD
Organizational Affiliation
Spain - Hospital Universitario Ramón y Cajal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raza Malik, MD
Organizational Affiliation
MA - Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Busch, MD
Organizational Affiliation
Germany - Medizinische Hochschule Hannover
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anupama Duddempudi, MD
Organizational Affiliation
NY - North Shore University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco Antonio Olivera-Martinez, MD
Organizational Affiliation
NE - University of Nebraska Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eckart Schott, MD
Organizational Affiliation
Germany - Charité Campus Virchow-Klinikum Medizinische Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Johns Hopkins University Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Minnesota Medical Center - Twin Cities Campus
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Rutgers University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Texas Health Science Center, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Charité Campus Virchow-Klinikum Medizinische Klinik
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Hospital Clinico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Hospital Universitario de Cruces
City
Baracaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Barts Health NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE59RS
Country
United Kingdom
Facility Name
Royal Free Hospital
City
Hampstead
State/Province
London
ZIP/Postal Code
NW3 2QR
Country
United Kingdom
Facility Name
NHS Tayside
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary
City
Doncaster
State/Province
South Yorkshire
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Brighton & Sussex University Hospitals NHS Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25009371
Citation
Pares A, Mas A. Extracorporeal liver support in severe alcoholic hepatitis. World J Gastroenterol. 2014 Jul 7;20(25):8011-7. doi: 10.3748/wjg.v20.i25.8011.
Results Reference
derived
Links:
URL
http://www.vitaltherapies.com
Description
Sponsor's website

Learn more about this trial

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

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