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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jul 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how certain genes may make people more likely to experience liver injury after taking acetaminophen (APAP), a common pain reliever. While acetaminophen is widely used, it has been found to cause liver problems in some individuals, especially in the United States. However, researchers noticed that the genetic factors linked to this issue in American populations might not apply to people in China. By examining a group of Chinese individuals who have taken acetaminophen, the study aims to identify genetic differences that could explain why some people are more susceptible to liver injury than others.

To participate in this trial, individuals must be at least 14 years old and have a clear history of taking acetaminophen or related drugs. They should also have had high levels of liver enzymes, which indicate liver stress or damage. Participants will undergo blood and urine tests to help researchers understand the connection between genetics and liver injury. Importantly, those with other known causes of liver disease or who are taking certain medications that can harm the liver will not be eligible. If you or someone you know is interested in contributing to this important research, please consider discussing it with a healthcare provider.

Gender

ALL

Eligibility 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.