RecruitingNCT04964310

Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study

Pharmacogenomics of APAP Induced DILI in Chinese Population.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

339 participants

Start Date

Aug 31, 2020

Study Type

OBSERVATIONAL

Conditions

China Pharmacogenetics Acetaminophen Drug-Induced Liver Injury

Summary

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.

Eligibility

Min Age: 14 Years

Inclusion Criteria5

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 Uclaf 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.

Exclusion Criteria5

The use of drugs for which frequency of adverse reactions to liver damage is defined as "common or very common" (≥1%) in the instructions.
Concurrent use of herbs that are clearly susceptible to liver damage (see list of definitions in the Annex).
Have a known definite cause of liver damage: active viral hepatitis; alcoholic liver disease; autoimmune liver disease; primary or secondary liver tumors; and other underlying liver disease that has affected liver function.
Those who fail to provide complete general information and clinical information.
Subjects or guardians who do not agree to see this project do not sign the informed consent form.

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