NCT02961413招募中不适用
A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China
Drug Induced Liver Disease Study Group1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2016年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover
研究概览
简要总结
This is a multi-center, prospective, non-interventional cohort study .
Its primary objectives are:
- assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice;
- learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.
详细描述
The main purpose of this study is to understand patients with DILI clinical outcome and influencing factors in China's second and tertiary general hospitals (including Western medicine hospital, Chinese medicine hospital andIntegrated traditional Chinese and Western Medicine Hospital) and vulnerabilities of drug-induced liver injury specialist hospital (tuberculosis hospital, Pulmonary, etc.) in mainland.
The main purpose
- assess the DILI patients' clinical outcomes and influencing factors in the real world;
- learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.
Secondary objectives
- assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.;
- evaluate the histological features of DILI patients;
- assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DILI patients with various types and severity according to the 2015 version of the Chinese DILI treatment guidelines
- •RUCAM ≥6, or RUCAM between 3-5 is required by the three experts determined that the drug-induced liver injury
- •patient can provide informed consent form
排除标准
- •non-drug-induced liver injury
结局指标
主要结局
Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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