CTRI/2011/12/002253已完成4 期
A Prospective Multicenter Observational Study to Characterize the Patient Population with Cholestasis in Chronic Liver Disease due to Alcoholic liver disease receiving Heptral in India. - ALD PMOS SAMe
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1)Chronic liver disease due to alcoholic liver disease as diagnosed by the physician
- •2)Intrahepatic cholestasis as diagnosed by the physician
- •3)Age 18 to 65 years.
- •4)Patients being prescribed Heptral according to local label.
- •5)Patient?s written authorization to provide data for the study.
排除标准
- •1)Contraindications to Heptral treatment including hypersensitivity according to the local label.
- •2)Pregnancy 1-2 trimester or lactation.
- •3)Hepatocellular or metastatic liver carcinoma.
- •4)Severe liver disease including but not limited to ascites, hepatic encephalopathy, hypoalbuminemia, coagulopathy.
- •5)Other conditions that make the patients participation impossible (by investigator judgment).
- •6)Patients receiving any hepatotoxic medications
研究者
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