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临床试验/NCT02407964
NCT02407964已完成不适用

A Retrospective Epidemiologic Study on Incidence and Treatment Status of Hospitalized Drug Induced Liver Injury Patients in Mainland China

Drug Induced Liver Disease Study Group370 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15,000
试验地点
370
主要终点
diagnosis of drug-induced liver injury

研究概览

简要总结

This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.

详细描述

This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.

It investigates medical records of patients who were hospitalized during 2012 to 2014. Those patients should be diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Any hospitalized patients who were diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.
  • The drug-induced liver injury and similar diagnosis were not excluded the possibility of drug-induced nature.

排除标准

  • Confirmed non-drug induced liver injury.
  • Insufficient clinical data supporting the diagnosis of drug-induced liver injury.
  • Liver injury resulted from poisons and chemicals.

结局指标

主要结局

diagnosis of drug-induced liver injury

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Drug Induced Liver Disease Study Group
申办方类型
Other
责任方
Sponsor

研究点 (370)

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