findmyKOL
Clinical trialNCT01471028CompletedPhase 3Interventional

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

SponsorVital Therapies, Inc.Enrollment203Acute Alcoholic Hepatitis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

45 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, Australia

  • Flinders Medical Centre

    Bedford Park, South Australia, Australia

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, Australia

Spain
  • Hospital Ramón Y Cajal

    Madrid, Spain

United Kingdom
  • King'S College Hospital

    London, England, United Kingdom

  • Royal Free Hospital

    Hamstead, London, United Kingdom

  • University Hospitals Birmingham Nhs Foundation Trust, Queen Elizabeth Hospital

    Birmingham, West Midlands, United Kingdom

  • United Hospitals Bristol Nhs Foundation Trust

    Bristol, United Kingdom

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, United Kingdom

  • Royal Infirmary of Edinburgh

    Edinburgh, United Kingdom

United States
  • Maricopa Integrated Health System (mihs)

    Phoenix, Arizona, United States

  • University of Arizona Medical Center

    Tucson, Arizona, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States

  • Sharp Coronado Hospital

    Coronado, California, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, United States

  • Keck Hospital of University of Southern California

    Los Angeles, California, United States

  • Stanford School of Medicine/stanford University Medical Center

    Palo Alto, California, United States

  • University of California San Diego Medical Center - Hillcrest

    San Diego, California, United States

  • Georgetown University Hospital

    Washington D.C., District of Columbia, United States

  • University of Miami Hospital

    Miami, Florida, United States

  • Tampa General Hospital

    Tampa, Florida, United States

  • Cleveland Clinic Florida

    Weston, Florida, United States

  • Emory University Hospital

    Atlanta, Georgia, United States

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, United States

  • Rush University Medical Center

    Chicago, Illinois, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • University of Minnesota - Twin Cities Campus

    Minneapolis, Minnesota, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, United States

  • Rutgers University Hospital

    New Brunswick, New Jersey, United States

  • North Shore University Hospital

    Manhasset, New York, United States

  • Columbia University Medical Center

    New York, New York, United States

  • New York University Langone Medical Center

    New York, New York, United States

  • Montefiore Medical Center

    The Bronx, New York, United States

  • Westchester Medical Center

    Valhalla, New York, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, United States

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, United States

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, United States

  • Baylor University Medical Center

    Dallas, Texas, United States

5 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ELAD treatment
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2013
Primary completion
31 Jan 2015
Completion
31 Aug 2015
Last update posted
15 Feb 2019
Registered enrollment
203
Registry id
NCT01471028

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.