Evidence map›Paper›PMID 34763711›Full record

ArticleTrials2021

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.

N Vergis, V Patel, K Bogdanowicz, J Czyzewska-Khan, F Fiorentino, E Day, M Cross, N Foster, E Lord, R Goldin and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03775109 (IL-1 Signal Inhibition in Alcoholic Hepatitis), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.2field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03775109 phase2completednot on this map

IL-1 Signal Inhibition in Alcoholic Hepatitis (ISAIAH)

TypeinterventionalSponsorImperial College LondonRan2019 to 2023Enrolled55ConditionsAlcoholic HepatitisArmsCanakinumab 150mg/ml solution for injection, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 22 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

N VergisDepartment of Metabolism, Digestion and Reproduction, Imperial College London, London, UK. nvergis@ic.ac.uk.ORCID http://orcid.org/0000-0002-4157-6757
V PatelInstitute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK.
K BogdanowiczImperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.
J Czyzewska-KhanImperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.
F FiorentinoImperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.
E DayImperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.
M CrossImperial Clinical Trials Unit, Department of Surgery and Cancer, Imperial College, London, UK.
N FosterDepartment of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.
E LordDepartment of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.
R GoldinDepartment of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.
E ForrestGlasgow Royal Infirmary and University of Glasgow, Glasgow, UK.
M ThurszDepartment of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.
Imperial College London · GBGlasgow Royal Infirmary · GBKing's College London · GB

Funding

Medical Research Council MR/R014019/1Wellcome TrustWellcome Trust 294834/Z/16/Z
6 · The paper itself

Abstract

backgroundAlcohol 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.

methodsThis is a 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 UK. Patients will receive an infusion of Canakinumab or matched placebo by random 1:1 allocation. The primary outcome is the difference between groups in the proportion of patients demonstrating histological improvement and will compare histological appearances at baseline with appearances at 28 days to assign a category of "improved" or "not improved". 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 signalling may improve histology and survival for patients with AH.

trial registrationEudraCT 2017-003724-79 . Prospectively registered on 13 April 2018.

Indexed as

Hepatitis, AlcoholicAntibodies, Monoclonal, HumanizedClinical Trials, Phase II as TopicDouble-Blind MethodHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAntibodies, Monoclonal, HumanizedcanakinumabAlcoholic hepatitisCanakinumabInterleukin 1β

Identifiers

PMID34763711
PMCPMC8581959
OpenAlexW3212645234

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.