RUCAM in Drug and Herb Induced Liver Injury: The Update.
Gaby Danan, Rolf Teschke
https://pubmed.ncbi.nlm.nih.gov/26712744Actively Recruiting
Age: 14Years +
All Genders
ID04964310
Pharmacogenomics of Acetaminophen-Induced Drug-Induced Liver Injury in Chinese Population
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-02-26
339
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
U
University of Colorado, Denver
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating genetic factors that might make some people in the Chinese population more likely to develop liver injury after taking acetaminophen (APAP), a common pain reliever. This study compares individuals who have experienced drug-induced liver injury (DILI) from APAP with those who have not, aiming to find genetic differences that could explain susceptibility. Previous genetic findings from U.S. populations did not apply well to Chinese individuals, so this research focuses specifically on a Chinese group. Participants are divided into two groups based on whether they developed liver injury after APAP use. Inclusion requires a clear history of acetaminophen ingestion or positive testing for its components, along with liver enzyme levels (ALT or AST) of 1000 IU/L or higher, and a causality score indicating APAP caused the injury. The study uses gene analysis methods, including genotyping over two million marker sites and immune gene typing, to identify genetic variations associated with liver injury risk. Strict protocols and quality controls ensure accurate data collection and management. During the study, participants provide clinical information and samples for genetic testing. Researchers collect data on acetaminophen exposure, liver enzyme levels, and causality assessments. The main outcome is the difference in genetic polymorphisms between those with and without liver injury, measured over two years. Data is carefully monitored and analyzed using statistical software to understand genetic links to APAP-induced liver injury. The study aims to improve understanding of genetic risks in this population and potentially guide safer medication use.
CONDITIONS
Brief Title
Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study
Who Can Participate
Age: 14Years +
All Genders
Eligibility Criteria
You may qualify if you...
- A clear history of acetaminophen (or acetaminophen-containing drugs) ingestion
- Plasma and/or urine testing for acetaminophen components if history of ingestion is unclear
- Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) 65 1000 IU/L at any time after acetaminophen administration
- Roussel Uclaf Causality Assessment Method (RUCAM) score greater than 6
- Age 14 years or older
- Subject or guardian agrees to participate and signs informed consent form
You will not qualify if you...
- Use of drugs known to commonly cause liver damage (frequency 651%)
- Concurrent use of herbs known to cause liver damage
- Known definite cause of liver damage such as active viral hepatitis, alcoholic liver disease, autoimmune liver disease, primary or secondary liver tumors, or other liver diseases affecting function
- Failure to provide complete general and clinical information
- Subject or guardian does not agree to participate or sign informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 2 years
Participants provide blood and/or urine samples for acetaminophen component testing and genetic polymorphism analysis to observe genetic susceptibility to drug-induced liver injury.
Periodic sample collections during study period
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Loading map...
Research Team
H
Hao Sun, professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Trends in rates of acetaminophen-related adverse events in the United States.
Jacqueline M Major, Esther H Zhou, Hui-Lee Wong...
https://pubmed.ncbi.nlm.nih.gov/26530380Population-based surveillance for acute liver failure.
William A Bower, Matthew Johns, Harold S Margolis...
https://pubmed.ncbi.nlm.nih.gov/17608778Updated guidelines for the management of paracetamol poisoning in Australia and New Zealand.
Angela L Chiew, David Reith, Adam Pomerleau...
https://pubmed.ncbi.nlm.nih.gov/31786822Efficacy of oral N-acetylcysteine in the treatment of acetaminophen overdose. Analysis of the national multicenter study (1976 to 1985).
M J Smilkstein, G L Knapp, K W Kulig...
https://pubmed.ncbi.nlm.nih.gov/3059186Acetaminophen is Undetectable in Plasma From More Than Half of Patients Believed to Have Acute Liver Failure Due to Overdose.
Thomas M Leventhal, Michelle Gottfried, Jody C Olson...
https://pubmed.ncbi.nlm.nih.gov/30731196Quantitative Method for Simultaneous Analysis of Acetaminophen and 6 Metabolites.
Laureen A Lammers, Roos Achterbergh, Marcel C M Pistorius...
https://pubmed.ncbi.nlm.nih.gov/28045783The Genomics of Elevated ALT and Adducts in Therapeutic Acetaminophen Treatment: a Pilot Study.
Andrew A Monte, Brandon Sonn, Jessica Saben...
https://pubmed.ncbi.nlm.nih.gov/33051802