ELAD for Treatment of AILD (VTI-208)
Research type
Research Study
Full title
A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF ELAD IN SUBJECTS WITH ALCOHOL-INDUCED LIVER DECOMPENSATION (AILD)
IRAS ID
126783
Contact name
Stephen Ryder
Contact email
Sponsor organisation
VITAL THERAPIES INCORPORATED
Eudract number
2012-005563-27
ISRCTN Number
N/A
Research summary
Acute decompensation of liver function can occur when alcohol is consumed by patients with alcoholic liver disease, and also by patients with chronic liver disease due to other etiologies. These patients, described for the purpose of this study as suffering from alcohol-induced liver decompensation (AILD).
Treatment options for patients with AILD are limited. Regimens that have been used for the past 40 years, including corticosteroids, theophylline with corticosteroids, pentoxifylline and infliximab, have had no significant effect on the long term survival of patients with AILD. Steroid use has been associated with an increased rate of infections, a complication of liver failure.
Conventional therapies such as hemodialysis and hemoperfusion do not correct the metabolic abnormalities that are the hallmark of acute liver failure.
Vital Therapies Incorporated (VTI) has developed the ELAD® system that comprises a dialysistype pump system and several “metabolically active” cartridges, each containing thousands of hollow fiber capillaries through which the subject’s plasma “ultrafiltrate” fluid is circulated.
ELAD therapy is designed to provide liver support continuously to a subject with compromised liver function, allowing time for the subject’s native liver to regenerate to a healthy state or to stabilize the subject until a suitable donor organ can be found for transplantation.
VTI-208 is a randomized, multicenter, open-label, concurrent control study designed to provide data on the safety and clinical utility of the ELAD system in the treatment of subjects with AILD. Approximately 200 evaluable subjects meeting the eligibility requirements of the study will be randomly assigned in a 1:1 ratio to receive either standard of care treatment for AILD (as defined in the protocol) plus treatment with the ELAD system (ELAD group) or standard of care treatment for AILD alone (Control group).REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0136
Date of REC Opinion
26 Jul 2013
REC opinion
Further Information Favourable Opinion