EUCTR2009-013897-42-GB进行中（未招募）1 期
STOPAH: STeroids Or Pentoxifylline for Alcoholic Hepatitis - STOPAH: STeroids Or Pentoxifylline for Alcoholic Hepatitis
Southampton University Hospitals NHS Trust R&D department0 个研究点目标入组 1,200 人开始时间: 2010年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
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
- •Aged 18 years or older Clinical Alcoholic Hepatitis: • Serum bilirubin > 80µmol/L • History of excess alcohol (> 80g/day male, > 60g/day female) to within 2 months of randomisation Less than 4 weeks since admission to hospital. Discriminant Function* greater than or equal to 32. Informed consent * DF = 4.6 x (Prothrombin time (PTPATIENT – PTCONTROL) + Serum Bilirubin (µmol/l) / 17.1, (PTCONTROL is defined as the mean value at each centre, this mean value may be updated on a weekly or monthly basis)
- •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 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Abstinence of more than 2 months prior to randomisation Duration of clinically apparent jaundice > 3 months Other causes of liver disease including: o Evidence of chronic viral hepatitis (Hepatitis B or C), o Biliary obstruction, o Hepatocellular carcinoma Evidence of current malignancy (except non-melanotic skin cancer) Previous entry into the study, or use of either prednisolone or prednisolone within 6 weeks of admission. AST >500 U/L or ALT >300 U/L. (not compatible with alcoholic hepatitis) Patients with a serum creatinine greater than 500 µmol/L or requiring renal support. Patients dependent upon inotropic support (adrenaline or noradrenaline). Glypressin is allowed. Active gastro-intestinal haemorrhage Untreated sepsis Patients with known hypersensitivity to pentoxifylline, other methyl xanthines or any of the excipients Patients with cerebral haemmorrhage, extensive retinal haemorrhage, acute myocardial infarction or severe cardiac arrhythmias Pregnant or lactating women Patients with evidence of sepsis, gastrointestinal bleeding or renal failure may be treated for these conditions for up to 7 days and then re-screened. Once the condition has been stabilised these patients will be randomised using stratified randomisation procedures. Recent gastrointestinal bleeding: Gastrointestinal bleeding will be treated and the patient stabilised for at least 48 hours prior to screening and randomisation. Sepsis: All patients will be screened for infection as part of routine care. Positive culture and initiation of antibiotics with clinical or radiological signs of infection; as well as clinical suspicion will be recorded as sepsis. Patients with evidence of sepsis will be treated for a minimum of 2 days with appropriate antibiotics. Once the local principal investigator considers that the sepsis is under control then the patient may be rescreened and randomised. Renal Impairment: Patients who are oligo-anuric, have a creatinine > 500 uM/L or who require renal support will be given appropriate resuscitation therapy for up to 1 week. These patients may then be rescreened and considered for randomisation once they meet eligibility criteria.
研究者
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