Imperial College London
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DrNikhilVergis

Faculty of Medicine, Department of Metabolism, Digestion and Reproduction

Honorary Clinical Senior Lecturer
 
 
 
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Contact

 

n.vergis

 
 
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Location

 

Norfolk PlaceSt Mary's Campus

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Summary

 

Publications

Citation

BibTex format

@article{Vergis:2021:10.1186/s13063-021-05719-2,
author = {Vergis, N and Patel, V and Bogdanowicz, K and Czyzewska-Khan, J and Fiorentino, F and Day, E and Cross, M and Foster, N and Lord, E and Goldin, R and Forrest, E and Thursz, M},
doi = {10.1186/s13063-021-05719-2},
journal = {Trials},
pages = {1--16},
title = {IL-1 Signal Inhibition In Alcoholic Hepatitis (ISAIAH): a study protocol for a multicentre, randomised, placebo controlled trial to explore the potential benefits of canakinumab in the treatment of alcoholic hepatitis},
url = {http://dx.doi.org/10.1186/s13063-021-05719-2},
volume = {22},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background: Alcohol consumption causes a spectrum of liver abnormalities and leads to over 3 million deaths per year. 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 aim of this study is to explore the potential benefits of the IL-1β antibody, Canakinumab, in the treatment of AH.Methods: This is multicentre, double-blind, randomised placebo-controlled trial. Participants will be diagnosed with AH using clinical criteria. Liver biopsy will then confirm that all histological features of AH are present. Up to 58 participants will be recruited into two groups from 15 centres in the United Kingdom. Patients will receive an infusion of Canakinumab or matched placebo by random 1:1 allocation. The primary outcome is reduction in lobular inflammation, comparing histological appearances at baseline with appearances at 28 days. Patients with evidence of ongoing disease activity will receive a second infusion of Canakinumab or placebo. Participants will be followed up for 90 days. Secondary outcomes include mortality and change in MELD score at 90 days. Discussion: This phase II study will explore the benefits of the IL-1β antibody, canakinumab, in the treatment of AH to provide proof of concept that inhibition of IL-1β signaling may improve histology and survival for patients with AH. Trial registration: Prospectively registered with EudraCT 2017-003724-79.
AU  - Vergis,N
AU  - Patel,V
AU  - Bogdanowicz,K
AU  - Czyzewska-Khan,J
AU  - Fiorentino,F
AU  - Day,E
AU  - Cross,M
AU  - Foster,N
AU  - Lord,E
AU  - Goldin,R
AU  - Forrest,E
AU  - Thursz,M
DO  - 10.1186/s13063-021-05719-2
EP  - 16
PY  - 2021///
SN  - 1745-6215
SP  - 1
TI  - IL-1 Signal Inhibition In Alcoholic Hepatitis (ISAIAH): a study protocol for a multicentre, randomised, placebo controlled trial to explore the potential benefits of canakinumab in the treatment of alcoholic hepatitis
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-021-05719-2
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05719-2
UR  - http://hdl.handle.net/10044/1/92658
VL  - 22
ER  -
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