Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

Summary

The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.

The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a chi-squared test.

Conditions

• Acute Alcoholic Hepatitis

Interventions

BIOLOGICAL

ELAD System

An extracorporeal human hepatic cell-based liver treatment

OTHER

Standard of Care (Control)

Standard medical treatment as defined by the protocol

Sponsors & Collaborators

• Vital Therapies, Inc.

  lead INDUSTRY

Principal Investigators

• Jan Stange, MD · Vital Therapies, Inc.

• David Reich, MD · PA - Drexel University

• Lance Stein, MD · GA - Piedmont Atlanta Hospital

• Nikolaos Pyrsopoulos, MD · NJ - Rutgers University Hospital

• Valentin Cuervas-Mons, MD · Spain - Hospital Universitario Puerta de Hierro Majadahonda

• Raza Malik, MD · MA - Beth Israel Deaconess Medical Center

• Nikunj Shah, MD · IL - Rush University Medical Center

• Simona Rossi, MD · PA - Albert Einstein Medical Center

• Juan Caballeria, MD · Spain - Hospital Clinic de Barcelona

• Ram Subramanian, MD · GA - Emory University Hospital

• Andres Duarte-Rojo, MD · AR - University of Arkansas for Medical Sciences

• Julie Thompson, MD · MN - University of Minnesota

• Peter R Galle, MD · Germany - Universitätsmedizin Mainz

• Hartmut H.-J. Schmidt, MD · Germany - Universitätsklinikum Münster

• Markus Busch, MD · Germany - Medizinische Hochschule Hannover

• Kristina Chacko, MD · NY - Montefiore Medical Center

• Talal Adhami, MD · OH - Cleveland Clinic Foundation

• Constance Mobley, MD, PhD · TX - Houston Methodist Hospital

• David J Kramer, MD · WI - Aurora St. Luke's Medical Center

• Stephen Caldwell, MD · VA - University of Virginia Health System

• Ali Al-Khafaji, MD · PA - University of Pittsburgh Medical Center

• Kalyan R Bhamidimarri, MD · FL - Schiff Center for Liver Diseases/University of Miami

• Manuel Romero-Gomez, MD · Spain - Hospital Universitario Virgen del Rocío

• Tarek Hassanein, MD · CA - Sharp Coronado Hospital

• Waldo Concepcion, MD · CA - Stanford University Medical Center

• Martin Prieto Castillo, MD · Spain - Hospital Universitario y Politécnico La Fe

• Rafael Bañares, MD · Spain - Hospital Universitario Gregorio Marañón

• Syed Naqvi, MD · MO - University of Missouri Hospital

• Matthias Dollinger, MD, PhD · Germany - Klinikum Landshut gemeinnuetzige GmbH

• Karen Krok, MD · PA - The Pennsylvania State University and The Milton S. Hershey Medical Center

• Rudolf Stauber, MD · Austria - Medizinische Universität Graz

• Christian Zauner, MD · Austria - Medizinische Universität Klinik Für Innere Medizin III

• Georg Lamprecht, MD · Germany - Universitätsmedizin Rostock

• Paul Thuluvath, MD · MD - Mercy Medical Center

• Trinidad Serrano Aullo, MD · Spain - Hospital Clínico Universitario Lozano Blesa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2018-03-31

Completion

2018-09-30

Countries

• United States
• Austria
• Germany
• Ireland
• Spain
• United Kingdom

Study Locations