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

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.

Conditions

• Acute Alcoholic Hepatitis

Interventions

BIOLOGICAL

ELAD treatment

ELAD treatment consists of treatment with an extracorporeal liver assist system.

OTHER

Standard of care (Control)

Control receives standard medical treatment.

Sponsors & Collaborators

• Vital Therapies, Inc.

  lead INDUSTRY

Principal Investigators

• 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

• 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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2015-01-31

Completion

2015-08-31

Countries

• United States
• Australia
• Spain
• United Kingdom

Study Locations