Actively Recruiting
Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-02-26
339
Participants Needed
1
Research Sites
330 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
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.
CONDITIONS
Official Title
Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A clear history of acetaminophen or acetaminophen-containing drug ingestion
- Plasma and/or urine testing for acetaminophen components if ingestion history is unclear
- Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) levels 1000 IU/L after APAP use and Roussel Uclaf Causality Assessment Method (RUCAM) score > 6 (for case group)
- Age 14 years or older
- Subject or guardian agrees to participate and signs informed consent
You will not qualify if you...
- Use of drugs with a common or very common (≥1%) frequency of liver damage adverse reactions
- Concurrent use of herbs known to cause liver damage
- Known definite causes of liver damage including active viral hepatitis, alcoholic liver disease, autoimmune liver disease, primary or secondary liver tumors, or other underlying liver diseases affecting liver function
- Incomplete general or clinical information provided
- Subject or guardian does not agree to participate or does not sign informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
H
Hao Sun, professor
CONTACT
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
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