IL-1 Signal Inhibition in Alcoholic Hepatitis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

* Male and female patients aged 18 years or older at screening
* Clinical diagnosis of alcoholic hepatitis at screening:
- Serum bilirubin > 80µmol/L
- History of excess alcohol (> 80g/day male, > 60g/day female) to within 6 weeks before screening visit
- Less than 4 weeks since admission to hospital at baseline visit
* mDF = 32 and MELD = 27 at baseline visit
* Informed consent
* Women of child-bearing potential have to use an effective contraception method (as defined in detail in study protocol)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Alcohol abstinence of >6 weeks prior to randomization/baseline visit
•Duration of clinically apparent jaundice > 3 months before baseline visit
•Other causes of liver disease including:
oEvidence of chronic viral hepatitis (Hepatitis B or C)
oBiliary obstruction
oHepatocellular carcinoma
•Evidence of current malignancy (except non-melanotic skin cancer)
•Previous entry into the study, or use of either prednisolone any systemic steroids (equivalent to a dose of systemic prednisolone >20mg) within 6 weeks of screening.
•AST >500 U/L or ALT >300 U/L (not compatible with alcoholic hepatitis)
•Patients with a serum creatinine >220 µmol/L (2.5 mg / dL) or requiring renal support
•Patients dependent upon inotropic support (adrenaline or noradrenaline). Terlipressin is allowed
•Variceal haemorrhage on this admission
•Untreated sepsis
•Patients with known hypersensitivity or contraindications to Canakinumab
•Patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction (within the last 6 weeks) or severe cardiac arrhythmias (not including atrial fibrillation)
•Pregnant or lactating women
•Patients treated with other IL-1 inhibitors and biologics or any other immunosuppressants within 3 months of study participation.
•Known infection with HIV at screening or randomization
History or evidence of tuberculosis (TB) (active or latent) infection
•History or evidence of tuberculosis (TB) (active or latent) infection
•Active ongoing inflammatory diseases other than AAH that might confound the evaluation of the benefit of canakinumab therapy
•Underlying metabolic, hematologic, renal, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, including neutropenia (ANC >1.5) and leukopenia, which in the opinion of the investigator immune-compromises the subject and/or places the subject at unacceptable risk for participation in an immunomodulatory therapy.
•Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (=160/95 mmHg), congestive heart failure [New York Heart Association status of class III or IV], uncontrolled diabetes
•Vaccination with a live vaccine within 3 month before baseline

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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