IL-1 Signal Inhibition in Alcoholic Hepatitis (ISAIAH)
The ISAIAH trial closed to patient recruitment in November 2020.
To explore the potential benefits of the IL-1β antibody, Canakinumab, in the treatment of alcoholic hepatitis.
Currently there is no effective treatment for severe alcoholic hepatitis. Based on our current understanding of the disease pathogenesis IL-1β is a key mediator of hepatic inflammation responsible for metabolic disturbances, fibrogenesis stellate cell activation and consequently portal hypertension. Canakinumab is a licensed monoclonal antibody inhibitor of IL-1β and may consequently reverse the adverse effects of the cytokine in patients with this disorder.
Multicentre, double blind, randomized (1:1), placebo controlled trial. The trial followed patients up for 90-days and was conducted in 15 centres across the United Kingdom. A total of 58 patients were recruited.
Patient Recruitment Sites
Aintree University Hospital
Bristol University Hospitals NHS Foundation Trust
Chelsea and Westminster Hospital, NHS Foundation Trust
Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde
Imperial College Healthcare NHS Trust
Kings College Hospital NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Oxford University Hospitals NHS Foundation Trust
Plymouth Hospitals NHS Trust
Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde
Royal Free London NHS Foundation Trust
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Southampton University Hospital Foundation Trust
The Newcastle Upon Tyne Hospitals NHS Foundation Trust