Identifying genetic factors for acetaminophen-induced liver injury in Chinese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the genetic susceptibility to drug-induced liver injury (DILI) caused by acetaminophen (APAP) in the Chinese population. Participants will be divided into case and control groups based on their history of APAP ingestion and liver enzyme levels. The study will utilize genetic polymorphism analysis to identify potential genetic markers associated with DILI. By comparing the genetic profiles of affected individuals with those who are not, the research seeks to uncover new pathogenic mechanisms underlying this condition.

Why it matters

Who can join: the full rules

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 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 criteria：

* 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.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Hao Sun, professor
• Email: haosun@njmu.edu.cn
• Phone: 13584017821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.