ELAD for Treatment of AAH (VTI-210)
Research type
Research Study
Full title
VTI-210: A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD in Subjects with Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure (incorporating VTI-210E as a Follow-up Registry)
IRAS ID
131219
Contact name
Stephen Ryder
Contact email
Sponsor organisation
VITAL THERAPIES INCORPORATED
Eudract number
2013-001884-21
ISRCTN Number
N/A
Research summary
Acute alcoholic hepatitis (AAH), generally defined as progressive inflammatory liver disease leading to an acute form of alcohol-induced liver injury that occurs with the consumption of large amounts of alcohol over a prolonged period of time.
Treatment options for patients with AAH are limited. Regimens that have been used for the past 40 years have had no significant effect on the long term survival of patients with AAH.
Conventional therapies such as hemodialysis and hemoperfusion do not correct the metabolic abnormalities that are the hallmark of acute liver failure.Vital Therapies Incorporated has developed the ELAD® system that is composed of a dialysis-type 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-210 is designed to provide data on the safety and clinical utility of the ELAD system in the treatment of subjects with AAH who have failed steroid therapy.
The study will be conducted at up to 45 centers in the United States, Australia, and Europe. In addition, ELAD treatment must take place in an Intensive Care Unit (ICU) or equivalent.
During the Screening phase a standard of care course of daily steroid therapy will be administered for a total of 7 (up to 9) days.Subjects considered “steroid non-responders” and eligible will be randomized into the Treatment phase.
They will stop steroid therapy and will be randomly assigned in a 1:1 ratio to receive either standard of care treatment for AAH plus treatment with the ELAD system, or standard of care treatment for AAH alone
Subjects randomized to the ELAD group will be treated with ELAD for a minimum of 3 days.
Randomized subjects in both the Control and ELAD groups will be evaluated throughout the 91-day study period.
Subjects who complete the Treatment phase of the study will be eligible for entry into the VTI-210E follow-up registry.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0147
Date of REC Opinion
26 Jul 2013
REC opinion
Further Information Favourable Opinion