ISRCTN88782125已完成3 期
STOPAH: STeroids Or Pentoxifyline for Alcoholic Hepatitis
Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 1,068 人开始时间: 2009年6月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,068
研究概览
简要总结
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23958271 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25901427 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26691209 2020 results in https://pubmed.ncbi.nlm.nih.gov/33326633/ (added 17/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Clinical alcoholic hepatitis:
- •1.1. Serum bilirubin greater than 80 µmol/L
- •1.2. History of excess alcohol (greater than 80 g/day male, greater than 60 g/day female)
- •2. Less than 4 weeks from admission to hospital
- •3. Discriminant Function (DF) greater than or equal to 32
- •4. Informed consent
- •5. Minimum 18 years old, no upper limit, either sex
排除标准
- •1. Abstinence of more than 6 weeks prior to randomisation
- •2. Duration of jaundice greater than 3 months
- •3. Other causes of liver disease
- •4. Evidence of current malignancy (except non-melanotic skin cancer)
- •5. Previous entry into the study, or use of either prednisolone or PTX within 6 months
- •6. Aspartate aminotransferase (AST) greater than 500 or alanine aminotransferase (ALT) greater than 300
- •7. Patients with a serum creatinine greater than 500 µmol/L or requiring renal support
- •8. Patients dependent upon inotropic support
- •9. Active gastro-intestinal haemorrhage and untreated sepsis
研究者
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