Identifying genetic factors for acetaminophen-induced liver injury in Chinese patients
Pharmacogenomics of APAP Induced DILI in Chinese Population.
This study is trying to find out if certain genes make Chinese patients more likely to have liver problems from taking acetaminophen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 339 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT04964310 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14 and older with a clear history of acetaminophen ingestion and elevated liver enzymes.
Not a fit: Patients with known liver diseases or those taking medications that commonly cause liver damage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and prevention of acetaminophen-induced liver injury in patients.
How similar studies have performed: While previous studies have explored genetic susceptibility to DILI in other populations, this specific focus on the Chinese population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.