Pharmacogenomics of APAP Induced DILI in Chinese Population.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 339
- 试验地点
- 1
- 主要终点
- genetic polymorphism
研究概览
简要总结
Acetaminophen (APAP) is the most commonly used NSAIDS in clinic, and it is also a common cause of drug-induced liver injury (DILI). In 2012, the proportion of DILI caused by APAP in the United States was 51%, while in Asia, it was only 7.10%. Previously, a small cohort study in the United States screened for some of the susceptibility genes for DILI due to APAP by the Genome wide association study (GWAS) method. However, the genetic susceptibility loci based on the US cohort were not applicable to the Chinese population. Therefore, we make a study design include Chinese population who ingested APAP and divided them into case group and control group according to the occurrence of DILI. We hope to be able to find the root of differences at the genetic level and explore new pathogenic mechanisms.
详细描述
I. Study Object
(i) Into the group strategy: continuous into group.
(ii) Grouping strategy：
- Case group.
Inclusion criteria：
- A clear history of acetaminophen (or acetaminophen-containing drugs) ingestion.
- Plasma and/or urine testing for acetaminophen components if history of ingestion is unclear.
- Monitoring of Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 1000 IU/L at any time after APAP administration and Roussel Causality Assessment Method(RUCAM) score > 6
- Age ≥ 14 years old.
- The subject or guardian agrees to participate in this project and signs an informed consent form.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
genetic polymorphism
时间窗: 2 year
the genetic polymorphism（HLA、SNPs ）frequency difference between case and control groups
次要结局
未报告次要终点
研究者
Hao Sun
associate professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School