EUCTR2017-003724-79-GB进行中（未招募）1 期
IL-1 Signal Inhibition in Alcoholic Hepatitis (Isaiah) - IL-1 Signal Inhibition in Alcoholic Hepatitis (Isaiah)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •* 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
排除标准
- •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
研究者
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