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NCT00832273

Use of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Liver Failure: Uncontrolled Treatment Protocol to Provide Expanded Access With Cost Recovery

NO LONGER AVAILABLE Last updated 9 September 2013
What this trial tests

trial testing ELAD® in Liver Failure. No longer available.

Quick facts

Lead sponsorVital Therapies, Inc.
StatusNO LONGER AVAILABLE
Study typeEXPANDED_ACCESS

Drugs / interventions tested

Conditions studied

Sponsor

Vital Therapies, Inc. — full company profile →

Who can join

Adults 10 to 70, any sex, with Liver Failure.

Sponsor's own description

VTI had established other clinical protocols to study the effects of ELAD® plus standard therapy compared with standard therapy alone in patients with acute on chronic (AOCH) (VTI-201, VTI-206) and fulminant hepatic failure (FHF) (VTI-202) and acute alcoholic hepatitis (AAH). However, liver failure (LF) patients who do not qualify for other protocols may benefit from ELAD use. In order to accommodate physician requests for the use of ELAD in LF patients who do not qualify for open Protocols, without the need to resort to individual Emergency Use INDs for each case, VTI has developed a Treatment Protocol with Cost Recovery to provide for expanded access to ELAD for those with LF. This uncontrolled Treatment Protocol has been designed to provide expanded access to ELAD in subjects with LF while assuring that sufficient data are collected to adequately monitor ELAD safety when used in this setting at multiple centers in the United States.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Liver Failure

Currently open trials in the same condition.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing