Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030225
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2002-02-11
Brief Title:
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
Sponsor:
Vital Therapies Inc
Organization:
Vital Therapies Inc
Study Overview
Official Title:
Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device ELAD System in the Management of the Patients With Fulminant Hepatic Failure
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery
Detailed Description:
Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None