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IL-1 Signal Inhibition in Alcoholic Hepatitis (ISAIAH)

The ISAIAH trial closed to patient recruitment in November 2020.
Objective:
To explore the potential benefits of the IL-1β antibody, Canakinumab, in the treatment of alcoholic hepatitis. 
Rationale:
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. 
Design:
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

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ISAIAH Newsletter 

June 2019

February 2020

August 2020