Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)

Summary

This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in subjects with acute liver failure (ALF) compared to matched historical controls.

Conditions

• Acute Liver Failure
• Fulminant Hepatic Failure
• Primary Graft Non-Function
• Surgically-Induced Liver Failure

Interventions

BIOLOGICAL

ELAD

Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).

Sponsors & Collaborators

• Vital Therapies, Inc.

  lead INDUSTRY

Principal Investigators

• Jan Stange, MD, Ph.D. · Vital Therapies, Inc.

• Parvez Mantry, MD · TX - Methodist Dallas Medical Center - The Liver Institute

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

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

• Juan Gallegos-Orozco, MD · UT - University of Utah

• Angel Alsina, MD · FL - Tampa General Hospital

• Lewis W Teperman, MD · NY - New York University Medical Center

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

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

• Winfred W Williams, Jr., MD · MA - Massachusetts General Hospital

• Lance Stein, MD · GA - Piedmont Atlanta Hospital

• Ram Subramanian, MD · GA - Emory University Hospital

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

• Marquis Hart, MD · WA - Swedish Medical Center

• Rohit Satoskar, MD · DC - Georgetown University Hospital

• Talal Adhami, MD · OH - Cleveland Clinic Foundation

• Linda S Sher, MD · CA - Keck Hospital of USC

• Xaralambos Zervos, DO · FL - Cleveland Clinic Florida

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

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2015-09-30

Completion

2018-09-30

Countries

• United States

Study Locations