A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Alcohol-Induced Liver Decompensation (AILD)
Sponsor study identifier
interventional
203
4 countries
45
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2011
Actual (reported)November 11, 2011
Actual (reported)February 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)August 2015
Actual (reported)February 15, 2019
Actual (reported)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).
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)
Number of Survivors at Study Day 91.
Up to Study Day 91.
Number of Progression-free Survivors at Study Day 91
Study Day 1 up to Study Day 91
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.
ELAD treatment consists of treatment with an extracorporeal liver assist system.
Control receives standard medical treatment.
Maricopa Integrated Health System (MIHS)
Phoenix, Arizona, 85008, United States
University of Arizona Medical Center
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Sharp Coronado Hospital
Coronado, California, 92118, United States
Keck Hospital of University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford School of Medicine/Stanford University Medical Center
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.
Jan Stange, MD
Vital Therapies, Inc.
David J Reich, MD
PA - Drexel University College of Medicine
Ram Subramanian, MD
GA - Emory University Hospital
Lewis Teperman, MD
NY - New York University Langone Medical Center
203 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2011
First Posted
November 11, 2011
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Palo Alto, California, 94304, United States
University of California San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Minnesota - Twin Cities Campus
Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Rutgers University Hospital
New Brunswick, New Jersey, 08903, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15216, United States
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
The University of Texas Health Science Center - Texas Liver Institute
San Antonio, Texas, 78215, United States
University of Utah Hospital
Salt Lake City, Utah, 84108, United States
Swedish Medical Center - Transplant Program
Seattle, Washington, 98104, United States
University of Washington - Harborview Medical Center
Seattle, Washington, 98104, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
Hospital Ramón y Cajal
Madrid, 28034, Spain
King's College Hospital
London, England, SE5 9RS, United Kingdom
Royal Free Hospital
Hamstead, London, NW3 2QG, United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, West Midlands, B152TH, United Kingdom
United Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8HW, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB20QQ, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Robert Brown, MD
NY - Columbia University Medical Center
Julie Thompson, MD
MN - University of Minnesota Medical Center - Twin Cities Campus
Paul Gaglio, MD
NY - Montefiore Medical Center
Linda Sher, MD
CA - Keck Hospital of University of Southern California
David Wolf, MD
NY - Westchester Medical Center
Parvez Mantry, MD
TX - Methodist Dallas Medical Center
Ali Al-Khafaji, MD
PA - University of Pittsburgh Medical Center
Marquis E Hart, MD
WA - Swedish Medical Center - Transplant Program
David Bernstein, MD
NY - North Shore University Hospital
Sumeet K Asrini, MD
TX - Baylor University Medical Center
Thomas Ardiles, MD
AZ - Maricopa Integrated Health System
Charles Landis, MD
WA - University of Washington - Harborview Medical Center
Rohit Satoskar, MD
DC - Georgetown University Hospital
Nikunj Shah, MD
IL - Rush University Medical Center
Brian Borg, MD
MS - University of Mississippi Medical Center
Alan Wigg, MD
South Australia - Flinders Medical Centre - Bedford Park
Gary Jeffrey
Western Australia - Sir Charles Gairdner Hospital - Nedlands
Lance L Stein, MD
GA - Piedmont Atlanta Hospital
Talal Adhami, MD
OH - Cleveland Clinic Foundation
Simona Rossi, MD
PA - Albert Einstein Medical Center
Anne McCune, MD
UK - Bristol - United Hospitals Bristol NHS Foundation Trust
Ahmed M Elsharkawy, MD
UK - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Andre Duarte-Rojo, MD
AR - University of Arkansas for Medical Sciences
Angel Alsina, MD
FL - Tampa General Hospital
Jag Sunderram, MD
NJ - Rutgers University Hospital
Geoffrey McCaughan, MD
Australia - Royal Prince Alfred Hospital - New South Wales
Raza Malik, MD
MA - Beth Israel Deaconess Medical Center
Juan Gallegos-Orozco, MD
UT - University of Utah Hospital
Tarek I Hassanein, MD
CA - Sharp Coronado Hospital
Shahid Habib, MD
AZ - University of Arizona Medical Center
Winfred W Williams, MD
MA - Massachusetts General Hospital
Pedram Enayati, MD
CA - Cedars-Sinai Medical Center
Michael Allison, MD
UK - England - Cambridge University Hospitals NHS Foundation Trust
Rajiv Jalan, MD
UK - England - Royal Free Hospital
Alexander Kuo, MD
CA - University of California San Diego Medical Center - Hillcrest
Alasdair Hay, MD
UK - Scotland - Royal Infirmary of Edinburgh
Agustin Albillos, MD
Spain - Madrid - Hospital Ramón y Cajal
Kalyan R Bhamidimarri, MD
FL - University of Miami Hospital
Xaralambos (Bobby) Zervos, DO
FL - Cleveland Clinic Florida
Waldo Concepcion, MD
CA - Stanford School of Medicine/Stanford University Medical Center
Julia A Wendon, MD
UK - England - King's College Hospital
Fred Poordad, MD
TX - The University of Texas Health Science Center - Texas Liver Institute
Primary Completion
January 2015
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
February 15, 2019
Results First Posted
February 15, 2019
Record last verified: 2019-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: