Alcoholic hepatitis (AH) is a florid presentation of alcoholic liver disease characterized by
liver failure in the context of recent and heavy alcohol consumption. The condition carries a
high fatality risk; patients with severe AH have a 30% mortality rate at 90 days after
presentation.
Currently there is no effective treatment for severe alcoholic hepatitis. Based on our
current understanding of the disease pathogenesis IL-1 (interleukin) 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-1 and may consequently reverse
the adverse effects of the cytokine in patients with this disorder. Therefore, the main
objective of the ISAIAH trial is to explore the potential benefits of the IL-1β antibody,
Canakinumab (solution for injection), in the treatment of alcoholic hepatitis.
ISAIAH is a multicentre, double blind, randomized (1:1), placebo controlled trial. The trial
will follow patients up for 90 days and will be conducted in centres across the United
Kingdom. Twenty-six patients will be recruited to each arm of the trial: total 52 patients.