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临床试验/CTRI/2011/12/002191
CTRI/2011/12/002191已完成4 期

A Prospective Multicenter Observational Study to Characterize the Patient Population with Cholestasis in Chronic Liver Disease due to Non-Alcoholic Liver Disease Receiving Heptral in India - SAMe NALD PMOS

Abbott India Limited0 个研究点目标入组 250 人开始时间: 待定最近更新:

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

  • Chronic liver disease due to non-alcoholic liver
  • disease as diagnosed by the physician
  • - Intrahepatic cholestasis as diagnosed by the
  • - Age 18 to 65 years.
  • - Patients being prescribed Heptral according to
  • local label
  • - Patient?s written authorization to provide data
  • for the study

排除标准

  • -Contraindications to Heptral treatment including
  • hypersensitivity according to the local label.
  • -Pregnancy 1-2 trimester or lactation
  • -Hepatocellular or metastatic liver carcinoma.
  • -Severe liver disease including but not limited to
  • ascites, hepatic encephalopathy, hypoalbuminemia,
  • coagulopathy
  • -Other conditions that make the patients
  • participation impossible (by investigator
  • -Patients receiving any hepatotoxic medications
  • -Previous enrollment in the present study

研究者

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