Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mark Thursz, MBBS MD FRCP 02075940995
isaiah@imperial.ac.uk


Justyna Czyzewska-Khan 02075941687
isaiah@imperial.ac.uk


Study Location:

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Be Part of Research - Trial Details - IL-1 Signal Inhibition in Alcoholic Hepatitis

IL-1 Signal Inhibition in Alcoholic Hepatitis

Medical Conditions

Hepatitis A
Hepatitis
Hepatitis, Alcoholic


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2018 May 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Canakinumab 150mg/ml solution for injection

Intervention Arm Group : Canakinumab 150mg/ml solution for injection;

Intervention Type : DRUG
Intervention Description : 100ml 5% Dextrose

Intervention Arm Group : Dextrose;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Free London NHS Foundation Trust
    London
  • Plymouth Hospitals NHS Trust
    Plymouth
  • University Hospital Southampton NHS Foundation Trust
    Southampton
  • University Hospitals Bristol NHS Foundation Trust
    Bristol
  • Leeds Teaching Hospitals NHS Trust
    Leeds
  • Royal Liverpool and Broadgreen University Hospitals NHS Trust
    Liverpool
  • St George's University Hospitals NHS Foundation Trust
    London
  • Queen Elizabeth University Hospital
    Glasgow
  • Aintree University Hospital
    Liverpool
  • Chelsea and Westminster Hospital NHS Foundation Trust
    London
  • Glasgow Royal Infirmary, Greater Glasgow & Clyde
    Glasgow
    G4 0SF
  • Imperial College Healthcare NHS Foundation Trust
    London
    W2 1NY
  • John Radcliffe Hospital, Oxford University NHS Foundation Trust
    Oxford
    OX3 9DU
  • King's College Hospital NHS Foundation Trust
    London
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Newcastle Upon Tyne
  • Nottingham University Hospitals NHS Trust
    Nottingham

Justyna Czyzewska-Khan 02075941687
isaiah@imperial.ac.uk


Mark Thursz, MBBS MD FRCP 02075940995
isaiah@imperial.ac.uk



The study is sponsored by Imperial College London and is in collaboration with Novartis Pharmaceuticals.




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Read full details for Trial ID: NCT03775109
Last updated 09 February 2023

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