A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 13
- 主要终点
- acute liver failure
研究概览
简要总结
A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers.
A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .
详细描述
Research Objectives:
- To establish a standardized multi-center, prospective DILI cohort nationwide and obtain long-term prognostic data.
- To establish and verify prognostic model(s) of DILI in China.
- To explore novel serum biomarkers for the prognosis of DILI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.
- •RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.
- •Onset to enrollment ≤3 months.
排除标准
- •Hepatotropic viral infection: hepatitis A, B, C, D and E.
- •Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
- •Hypoxic ischemic hepatitis and congestive liver disease.
- •Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
- •Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
- •Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
- •Parasitic infection.
- •Previous liver transplantation or bone marrow transplantation.
- •Pregnancy or lactation.
- •Genetic and metabolic liver diseases.
结局指标
主要结局
acute liver failure
时间窗: 1 year
Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompanied by mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.
death/liver transplantation
时间窗: 1 year
DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) . DILI is the primary indication for liver transplantation.
次要结局
- chronic DILI(2 years)
- recovery(2 years)
研究者
Zhao Xinyan
Professor
Beijing Friendship Hospital