To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure

Summary

The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score \>0.45).

Conditions

• Severe Acute Alcoholic Hepatitis

Interventions

BIOLOGICAL

ELAD

ELAD is an extracorporeal system that draws blood from the subject via a dual-lumen catheter placed in a large vein, and then separates the plasma fluid (ultrafiltrate) from cellular components using a specifically-designed ultrafiltrate generator cartridge. While the cellular components are returned to the subject via the venous access, the ultrafiltrate is circulated at a high flow rate through the four metabolically-active ELAD cartridges which contain cloned, immortalized human hepatoblastoma cells (VTL C3A cells) derived from a subclone of the human hepatoblastoma cell line HepG2.

OTHER

Standard of Care treatment

Standard of care treatment is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.

Sponsors & Collaborators

• Vital Therapies, Inc.

  lead INDUSTRY

Principal Investigators

• Jan Stange, MD · Vital Therapies, Inc.

• Rajiv Jalan, MD · UK - Royal Free Hospital

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

• José Luis Montero, MD · Spain - Hospital Reina Sofia

• Rafael Bañares, MD · Spain - Hospital Gregorio Marañon

• Kalyan R Bhamidimarri, MD · FL - University of Miami Hospital

• Julie Thompson, MD · MN - University of Minnesota Medical Center - Twin Cities Campus

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

• Santiago Tome, MD · Spain - Hospital Clinico Universitario de Santiago de Compostela

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

• Sumita Verma, MD · UK - Brighton & Sussex University Hospitals NHS Trust

• Paul J Gaglio, MD · NY - Montefiore Medical Center

• Manuel Romero-Gomez, MD · Spain - Hospital Universitario de Valme

• Andrew deLemos, MD · NC - Carolinas Medical Center

• Joanna Sayer, MD · UK - Doncaster Royal Infirmary

• Lance Stein, MD · GA - Piedmont Atlanta Hospital

• Javier Crespo, MD · Spain - Hospital Universitario Marques de Valdecilla

• Rohit Satoskar, MD · DC - Georgetown University Hospital

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

• David Reich, MD · PA - Drexel University College of Medicine

• Anne M Larson, MD · WA - Swedish Medical Center

• Xaralambos Zervos, DO · FL - Cleveland Clinic Florida

• Kirti Shetty, MD · MD - Johns Hopkins University Hospital

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

• Ram Subramanian, MD · GA - Emory University Hospital

• Alexander Kuo, MD · CA - University of California San Diego

• Talal Adhami, MD · OH - Cleveland Clinic Foundation

• Maria Jesús Suárez, MD · Spain - Hospital Universitario de Cruces

• Nikolaos T Pyrsopoulos, MD · NJ - Rutgers University Hospital

• Julio Gutierrez, MD · TX - University of Texas Health Science Center, San Antonio

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

• Agustín Albillos, MD · Spain - Hospital Universitario Ramón y Cajal

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

• Markus Busch, MD · Germany - Medizinische Hochschule Hannover

• Anupama Duddempudi, MD · NY - North Shore University Hospital

• Marco Antonio Olivera-Martinez, MD · NE - University of Nebraska Medical Center

• Eckart Schott, MD · Germany - Charité Campus Virchow-Klinikum Medizinische Klinik

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2015-10-31

Completion

2018-09-30

Countries

• United States
• Germany
• Spain
• United Kingdom

Study Locations