Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Death/Liver transplantation
研究概览
简要总结
The goal of this observational study is to screening for clinical, pathological and HLA features in patients with recurrent drug-induced liver injury. The main question it aims to answer is: Which patients with drug-induced liver injury need to be more cautious when re-dosing?
详细描述
Research Objectives:
- To summarise the clinicopathological characteristics of patients with recurrent drug-induced liver injury (DILI) in the Liver Disease Centre of Beijing Friendship Hospital in the past 10 years.
- Compare the differences in clinicopathological characteristics between patients with only one episode of different drug use and those with recurrent DILI, and predict the risk/protective factors in patients with recurrent DILI.
- Explore the susceptibility genes in patients with recurrent DILI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Inclusion criteria for recurrent drug induced liver injury:
- •Liver enzymes returns to normal or has a tendency to remission after the first drug liver injury;
- •Signs and symptoms of liver injury after the patient takes the different drugs for liver injury again, and the liver enzymes returns to normal through follow-up.
- •Inclusion criteria for drug induced liver injury:
- •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
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.
Recovery
时间窗: 1 year
Recovery status is defined as clinical and biochemical resolution within 1 year after DILI onset, with alanineaminotransferase (ALT) or aspartate aminotransferase (AST) ≤40 U/L, alkaline phosphatase (ALP) ≤150 U/L, and totalbilirubin (TB) ≤1.5 upper limits of normal (ULN) (25.65 μmol/L).
Acute Liver Failure
时间窗: 1 year
Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompaniedby mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.
次要结局
- chronic DILI(2 years)
研究者
Zhao Xinyan
Professor
Beijing Friendship Hospital