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Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery

NCT00832273 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2013-09-10

No results posted yet for this study

Summary

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.

Conditions

  • Liver Failure

Interventions

DEVICE

ELAD®

liver assist system

Sponsors & Collaborators

  • Vital Therapies, Inc.

    lead INDUSTRY

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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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 NCT00832273 on ClinicalTrials.gov