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Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency

NCT00771446 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-04-12

No results posted yet for this study

Summary

Evaluate on how well the ELAD system works in treating people with liver failure.

Conditions

  • Acute Hepatitis
  • Chronic Hepatitis

Interventions

OTHER

Standard of care treatment

Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)

BIOLOGICAL

ELAD plus standard of care treatment

ELAD is a liver assist system - Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)

Sponsors & Collaborators

  • Vital Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Todd Frederick, MD · California Pacific Medical Center

  • Donald Hillebrand, MD · Scripps Green Hospital

  • Helen Te, MD · University of Chicago

  • Robert Brown, MD · Columbia University

  • Lena Napolitano, MD · University of Michigan Hospital

  • Winfred Williams, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00771446 on ClinicalTrials.gov