ELAD for treatment of alcohol induced liver decompensation (VTL-308)
Research type
Research Study
Full title
A Randomised, Open-label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects with Alcohol-Induced Liver Decompensation (AILD)
IRAS ID
199790
Contact name
Stephen Ryder
Contact email
Sponsor organisation
Vital Therapies Inc
Eudract number
2015-004529-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CI/2015/0056, MHRA Device
Duration of Study in the UK
6 years, 2 months, 28 days
Research summary
The VTL-308 study compares treatment with the ELAD System, along with standard medical care, with standard medical care alone in participants with acute liver disease caused by excessive alcohol consumption.
ELAD System is designed to treat liver failure by drawing blood from a large vein, and circulating it outside the body through a special filter to separate out the blood cells from the plasma fluid. The plasma is then pumped through cartridges that contain billions of living human liver-like cells that have been specially selected because they provide certain substances believed necessary to support liver function and regeneration. After treatment, the plasma fluid is re-mixed with the blood cells and returned to the participant. Continuous treatment for up to 5 days may help recovery of the participant’s liver, and promote its regeneration.Participants will be selected for inclusion in the study based on evidence of the involvement of alcohol consumption in their condition, along with blood tests that define the severity of their liver failure. They will be excluded from participation if they have evidence of kidney problems or abnormal blood clotting, or are over the age of 50 years.
Participants will be randomly assigned to be treated with standard medical care, either with or without the ELAD System. If assigned to ELAD, participants will be treated up to 5 days (3-5 days), then both groups will be followed up for at least 91 days with scheduled clinic visits if they have been discharged from the hospital. The primary outcome of the study will be a comparison of the length of survival of the two groups in the study. Participants will also be asked to agree to telephonic follow-up for a total of 5 years.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1457
Date of REC Opinion
11 Oct 2016
REC opinion
Further Information Favourable Opinion