search
Back to results

Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure

Primary Purpose

Acute Alcoholic Hepatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ELAD treatment
Standard of care (Control)
Sponsored by
Vital Therapies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Alcoholic Hepatitis focused on measuring Acute alcoholic hepatitis, alcoholic, hepatitis, liver

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years;
  • Total bilirubin ≥ 8 mg/dL;
  • A clinical diagnosis of alcohol-induced liver decompensation (AILD), based upon evidence (by lab test, medical history, or family interview) of a clinical judgment of a temporal (6 weeks or less) and causal relationship between use of alcohol and this onset of symptoms;
  • Subjects meeting inclusion criteria 1 through 3 will be classified as having either:

    a. Severe acute alcoholic hepatitis (AAH), with: i. Medical history of alcohol abuse; AND ii. Maddrey score of ≥ 32; AND iii. AAH documented by either:

    1. Confirmatory liver biopsy; OR 2. Two or more of the following:

    1. Hepatomegaly,
    2. AST > ALT,
    3. Ascites,
    4. Leukocytosis (WBC count above lab normal at site), OR

    b. Alcohol-induced decompensation of chronic liver disease that is not acute alcoholic hepatitis (as defined above), with: i. MELD score of 18-35; AND ii. Underlying chronic liver disease documented by:

    1. Liver biopsy, AND/OR
    2. Laboratory findings, AND/OR
    3. Medical history;
  • Not eligible for liver transplant during this hospitalization;
  • Subject or legally authorized representative must provide Informed Consent;
  • Subject must be eligible for Standard of Care treatment as defined in the protocol.

Exclusion Criteria:

  • Platelet count < 40,000/mm3;
  • International Normalization Ratio (INR) > 3.5;
  • MELD Score > 35;
  • AST > 500 IU/L;
  • Evidence of infection unresponsive to antibiotics;
  • Evidence of reduction in total bilirubin of 20% or more in the previous 72 hours, if available. Bilirubin measurements must be taken at least 12 hours after any procedure known to artificially alter serum bilirubin (e.g., administration of packed red blood cells, plasma exchange);
  • Evidence of hemodynamic instability as defined by the following:

    1. Systolic blood pressure < 90 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
    2. Mean arterial pressure (MAP) < 60 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
    3. Requirement for escalating doses of vasopressor support prior to Screening; OR
    4. Subject at maximum vasopressor dose at Screening;
  • Evidence of active bleeding or of major hemorrhage defined as requiring ≥ 2 units packed red blood cells to maintain stable hemoglobin occurring within 48 hours of Screening;
  • Clinical evidence of liver size reduction due to cirrhosis (liver size of the craniocaudal diameter (sagittal view) < 10 cm when measured on the mid clavicular line (or equivalent measurement) by ultrasound, or liver volume < 750 cc as determined by CT), unless Investigator interpretation of the clinical evidence indicates liver size of < 10 cm or volume < 750 cc is not considered reduced for the individual subject;
  • 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, including, but not limited to:

    1. Severe acute or chronic cardiovascular, central nervous system, or pulmonary disease;
    2. Cancer that has metastasized or has not yet been treated;
  • Subject has chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome);
  • Subject has liver disease related to homozygous hemachromatosis, Wilson's Disease, has non-alcoholic fatty liver disease, or Budd-Chiari Syndrome;
  • Pregnancy as determined by β-human chorionic gonadotropin (HCG) results, or lactation;
  • 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 safety and/or efficacy of the VTI-208 clinical trial);
  • Previous liver transplant;
  • Previous enrollment in the treatment phase of another ELAD trial (e.g. a subject is not disqualified from enrollment in VTI-208 if they were screened for VTI-210 but did not qualify for enrollment in the treatment phase of the study and therefore did not receive ELAD or Control treatment;
  • Have a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or such 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-208E follow-up study;
  • Inability to provide an address for home visits.

Sites / Locations

  • Maricopa Integrated Health System (MIHS)
  • University of Arizona Medical Center
  • University of Arkansas for Medical Sciences
  • Sharp Coronado Hospital
  • Keck Hospital of University of Southern California
  • Cedars-Sinai Medical Center
  • Stanford School of Medicine/Stanford University Medical Center
  • University of California San Diego Medical Center - Hillcrest
  • Georgetown University Hospital
  • University of Miami Hospital
  • Tampa General Hospital
  • Cleveland Clinic Florida
  • Piedmont Atlanta Hospital
  • Emory University Hospital
  • Rush University Medical Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • University of Minnesota - Twin Cities Campus
  • University of Mississippi Medical Center
  • Rutgers University Hospital
  • Montefiore Medical Center
  • North Shore University Hospital
  • New York University Langone Medical Center
  • Columbia University Medical Center
  • Westchester Medical Center
  • Cleveland Clinic Foundation
  • Drexel University College of Medicine
  • Albert Einstein Medical Center
  • University of Pittsburgh Medical Center
  • Methodist Dallas Medical Center
  • Baylor University Medical Center
  • The University of Texas Health Science Center - Texas Liver Institute
  • University of Utah Hospital
  • Swedish Medical Center - Transplant Program
  • University of Washington - Harborview Medical Center
  • Royal Prince Alfred Hospital
  • Flinders Medical Centre
  • Sir Charles Gairdner Hospital
  • Hospital Ramón y Cajal
  • King's College Hospital
  • Royal Free Hospital
  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
  • United Hospitals Bristol NHS Foundation Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ELAD Treatment

Standard of care (Control)

Arm Description

This group will receive treatment with ELAD plus standard of care treatment.

This group will receive standard of care treatment as defined in the protocol.

Outcomes

Primary Outcome Measures

Overall Survival
The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTI-208E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (31 July 2015).

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2011
Last Updated
January 22, 2019
Sponsor
Vital Therapies, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01471028
Brief Title
Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
Official Title
A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Alcohol-Induced Liver Decompensation (AILD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
August 2015 (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 primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing additional survival data up to a maximum of 5 years that will be included, as available, through VTI-208 study termination (after the last surviving enrolled subject completes Study Day 91). Secondary objectives are to determine the proportion of survivors at Study Days 28 and 91. Exploratory objectives are to evaluate the ability of ELAD to stabilize liver function, measured using the Model for End Stage Liver Disease (MELD)-based time to progression (TTP) up to Study Day 91, and the proportion of progression-free survivors (PFS) up to Study Days 28 and 91. Progression is defined as death or the first observed increase of at least 5 points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to both End of Study Days 28 and 91 following Randomization.
Detailed Description
Subjects randomized to the ELAD® group will receive treatment with ELAD® for a maximum of five (5) 24 hour periods as well as standard of care treatment. Subjects randomized to the Control group will receive standard of care treatment throughout the study. The ITT population includes all randomized subjects assigned to the group to which they were randomized, irrespective of actual treatment administered. Participant, Baseline Characteristics, and Outcome Measures used the ITT population. The safety population is defined as all subjects who are randomized based on actual treatment received. All serious adverse events and all non-serious adverse events analyses used the safety population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Alcoholic Hepatitis
Keywords
Acute alcoholic hepatitis, alcoholic, hepatitis, liver

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ELAD Treatment
Arm Type
Experimental
Arm Description
This group will receive treatment with ELAD plus standard of care treatment.
Arm Title
Standard of care (Control)
Arm Type
Other
Arm Description
This group will receive standard of care treatment as defined in the protocol.
Intervention Type
Biological
Intervention Name(s)
ELAD treatment
Other Intervention Name(s)
ELAD
Intervention Description
ELAD treatment consists of treatment with an extracorporeal liver assist system.
Intervention Type
Other
Intervention Name(s)
Standard of care (Control)
Other Intervention Name(s)
Standard of care as defined by the protocol
Intervention Description
Control receives standard medical treatment.
Primary Outcome Measure Information:
Title
Overall Survival
Description
The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTI-208E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (31 July 2015).
Time Frame
Up to at least Study Day 91, with protocol VTI-208E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (31 July 2015)
Secondary Outcome Measure Information:
Title
Number of Survivors at Study Day 91.
Description
Assess the proportion of survivors at Study Day 91.
Time Frame
Up to Study Day 91.
Other Pre-specified Outcome Measures:
Title
Number of Progression-free Survivors at Study Day 91
Description
An exploratory objective is to evaluate the ability of ELAD® to stabilize liver function, measured using the MELD-based time to progression (TTP), with progression defined as death or the first observed increase of at least 5 points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to both End of Study Days 28 and 91 following Randomization.
Time Frame
Study Day 1 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 years; Total bilirubin ≥ 8 mg/dL; A clinical diagnosis of alcohol-induced liver decompensation (AILD), based upon evidence (by lab test, medical history, or family interview) of a clinical judgment of a temporal (6 weeks or less) and causal relationship between use of alcohol and this onset of symptoms; Subjects meeting inclusion criteria 1 through 3 will be classified as having either: a. Severe acute alcoholic hepatitis (AAH), with: i. Medical history of alcohol abuse; AND ii. Maddrey score of ≥ 32; AND iii. AAH documented by either: 1. Confirmatory liver biopsy; OR 2. Two or more of the following: Hepatomegaly, AST > ALT, Ascites, Leukocytosis (WBC count above lab normal at site), OR b. Alcohol-induced decompensation of chronic liver disease that is not acute alcoholic hepatitis (as defined above), with: i. MELD score of 18-35; AND ii. Underlying chronic liver disease documented by: Liver biopsy, AND/OR Laboratory findings, AND/OR Medical history; Not eligible for liver transplant during this hospitalization; Subject or legally authorized representative must provide Informed Consent; Subject must be eligible for Standard of Care treatment as defined in the protocol. Exclusion Criteria: Platelet count < 40,000/mm3; International Normalization Ratio (INR) > 3.5; MELD Score > 35; AST > 500 IU/L; Evidence of infection unresponsive to antibiotics; Evidence of reduction in total bilirubin of 20% or more in the previous 72 hours, if available. Bilirubin measurements must be taken at least 12 hours after any procedure known to artificially alter serum bilirubin (e.g., administration of packed red blood cells, plasma exchange); Evidence of hemodynamic instability as defined by the following: Systolic blood pressure < 90 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR Mean arterial pressure (MAP) < 60 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR Requirement for escalating doses of vasopressor support prior to Screening; OR Subject at maximum vasopressor dose at Screening; Evidence of active bleeding or of major hemorrhage defined as requiring ≥ 2 units packed red blood cells to maintain stable hemoglobin occurring within 48 hours of Screening; Clinical evidence of liver size reduction due to cirrhosis (liver size of the craniocaudal diameter (sagittal view) < 10 cm when measured on the mid clavicular line (or equivalent measurement) by ultrasound, or liver volume < 750 cc as determined by CT), unless Investigator interpretation of the clinical evidence indicates liver size of < 10 cm or volume < 750 cc is not considered reduced for the individual subject; 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, including, but not limited to: Severe acute or chronic cardiovascular, central nervous system, or pulmonary disease; Cancer that has metastasized or has not yet been treated; Subject has chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome); Subject has liver disease related to homozygous hemachromatosis, Wilson's Disease, has non-alcoholic fatty liver disease, or Budd-Chiari Syndrome; Pregnancy as determined by β-human chorionic gonadotropin (HCG) results, or lactation; 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 safety and/or efficacy of the VTI-208 clinical trial); Previous liver transplant; Previous enrollment in the treatment phase of another ELAD trial (e.g. a subject is not disqualified from enrollment in VTI-208 if they were screened for VTI-210 but did not qualify for enrollment in the treatment phase of the study and therefore did not receive ELAD or Control treatment; Have a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or such 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-208E follow-up study; Inability to provide an address for home visits.
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
David J Reich, MD
Organizational Affiliation
PA - Drexel University College of Medicine
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
Lewis Teperman, MD
Organizational Affiliation
NY - New York University Langone Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Brown, MD
Organizational Affiliation
NY - Columbia University Medical Center
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
Paul Gaglio, MD
Organizational Affiliation
NY - Montefiore Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Sher, MD
Organizational Affiliation
CA - Keck Hospital of University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Wolf, MD
Organizational Affiliation
NY - Westchester Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Parvez Mantry, MD
Organizational Affiliation
TX - Methodist Dallas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Al-Khafaji, MD
Organizational Affiliation
PA - University of Pittsburgh Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marquis E Hart, MD
Organizational Affiliation
WA - Swedish Medical Center - Transplant Program
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Bernstein, MD
Organizational Affiliation
NY - North Shore University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sumeet K Asrini, MD
Organizational Affiliation
TX - Baylor University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Ardiles, MD
Organizational Affiliation
AZ - Maricopa Integrated Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Landis, MD
Organizational Affiliation
WA - University of Washington - Harborview Medical Center
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
Nikunj Shah, MD
Organizational Affiliation
IL - Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Borg, MD
Organizational Affiliation
MS - University of Mississippi Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Wigg, MD
Organizational Affiliation
South Australia - Flinders Medical Centre - Bedford Park
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Jeffrey
Organizational Affiliation
Western Australia - Sir Charles Gairdner Hospital - Nedlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lance L Stein, MD
Organizational Affiliation
GA - Piedmont Atlanta Hospital
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
Simona Rossi, MD
Organizational Affiliation
PA - Albert Einstein Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne McCune, MD
Organizational Affiliation
UK - Bristol - United Hospitals Bristol NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed M Elsharkawy, MD
Organizational Affiliation
UK - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Duarte-Rojo, MD
Organizational Affiliation
AR - University of Arkansas for Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angel Alsina, MD
Organizational Affiliation
FL - Tampa General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jag Sunderram, MD
Organizational Affiliation
NJ - Rutgers University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geoffrey McCaughan, MD
Organizational Affiliation
Australia - Royal Prince Alfred Hospital - New South Wales
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
Juan Gallegos-Orozco, MD
Organizational Affiliation
UT - University of Utah Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek I Hassanein, MD
Organizational Affiliation
CA - Sharp Coronado Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahid Habib, MD
Organizational Affiliation
AZ - University of Arizona Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Winfred W Williams, MD
Organizational Affiliation
MA - Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedram Enayati, MD
Organizational Affiliation
CA - Cedars-Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Allison, MD
Organizational Affiliation
UK - England - Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajiv Jalan, MD
Organizational Affiliation
UK - England - Royal Free Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Kuo, MD
Organizational Affiliation
CA - University of California San Diego Medical Center - Hillcrest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alasdair Hay, MD
Organizational Affiliation
UK - Scotland - Royal Infirmary of Edinburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agustin Albillos, MD
Organizational Affiliation
Spain - Madrid - Hospital Ramón y Cajal
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
Xaralambos (Bobby) Zervos, DO
Organizational Affiliation
FL - Cleveland Clinic Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waldo Concepcion, MD
Organizational Affiliation
CA - Stanford School of Medicine/Stanford University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia A Wendon, MD
Organizational Affiliation
UK - England - King's College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred Poordad, MD
Organizational Affiliation
TX - The University of Texas Health Science Center - Texas Liver Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maricopa Integrated Health System (MIHS)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Sharp Coronado Hospital
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Keck Hospital of University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford School of Medicine/Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California San Diego Medical Center - Hillcrest
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
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
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
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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 - Twin Cities Campus
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Rutgers University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
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
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
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 Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
Country
United States
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas Health Science Center - Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Swedish Medical Center - Transplant Program
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington - Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
King's College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Free Hospital
City
Hamstead
State/Province
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B152TH
Country
United Kingdom
Facility Name
United Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB20QQ
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29171941
Citation
Thompson J, Jones N, Al-Khafaji A, Malik S, Reich D, Munoz S, MacNicholas R, Hassanein T, Teperman L, Stein L, Duarte-Rojo A, Malik R, Adhami T, Asrani S, Shah N, Gaglio P, Duddempudi A, Borg B, Jalan R, Brown R, Patton H, Satoskar R, Rossi S, Parikh A, ElSharkawy A, Mantry P, Sher L, Wolf D, Hart M, Landis C, Wigg A, Habib S, McCaughan G, Colquhoun S, Henry A, Bedard P, Landeen L, Millis M, Ashley R, Frank W, Henry A, Stange J, Subramanian R; VTI-208 Study Group. Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial. Liver Transpl. 2018 Mar;24(3):380-393. doi: 10.1002/lt.24986.
Results Reference
derived
Links:
URL
http://www.vitaltherapies.com
Description
Vital Therapies, Inc. website

Learn more about this trial

Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure

We'll reach out to this number within 24 hrs