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

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ClinicalTrials.gov Identifier: NCT04964310
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : July 16, 2021
Sponsor:
Collaborators:
University of Colorado, Denver
Beijing Genomics Institute
Nanjing Medical University
Information provided by (Responsible Party):
Hao Sun, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment
Acetaminophen Drug-Induced Liver Injury Pharmacogenetics China Genetic: genetic polymorphism

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Study Type : Observational
Estimated Enrollment : 339 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Pharmacogenomics of APAP Induced DILI in Chinese Population.
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2025

Group/Cohort Intervention/treatment
APAP_DILI

(①/②)+③+④:

① history of acetaminophen exposure ② abnormal acetaminophen concentration in blood or urine:≥150µg/mL after 4 hour ,≥4.5µg/mL at anytime,measurable ≥24 hours③ liver impairment:Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 1000 IU/L ④ liver impairment is caused by acetaminophen:Russel U-Calf Causality Assessment Method(RUCAM) causality score>6

Genetic: genetic polymorphism
Observe the genetic polymorphism frequency difference between case and control groups

APAP_NO-DILI(NDILI)

(①/②)not(③/④):

① history of acetaminophen exposure ② abnormal acetaminophen concentration in blood or urine:≥150µg/mL after 4 hour ,≥4.5µg/mL at anytime,measurable ≥24 hours③ liver impairment:ALT or AST ≥ 1000 IU/L④ liver impairment is caused by acetaminophen:RUCAM causality score>6




Primary Outcome Measures :
  1. genetic polymorphism [ Time Frame: 2 year ]
    the genetic polymorphism(HLA、SNPs )frequency difference between case and control groups


Biospecimen Retention:   Samples With DNA
whole blood for DNA extraction


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
history of acetaminophen exposure
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04964310


Contacts
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Contact: Hao Sun, professor 13584017821 ext 86 haosun@njmu.edu.cn

Locations
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China, Jiangsu
The First Affiliated Hospital with Nanjing Medical University Recruiting
Nanjing, Jiangsu, China
Contact: Jinghai Tang, professor    025-83284725    Jhtang305@126.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
University of Colorado, Denver
Beijing Genomics Institute
Nanjing Medical University
Investigators
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Study Chair: Jingsong Zhang, professor The First Affiliated Hospital with Nanjing Medical University
Additional Information:
Publications:

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Responsible Party: Hao Sun, associate professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04964310    
Other Study ID Numbers: FirstNanjingMUED
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hao Sun, The First Affiliated Hospital with Nanjing Medical University:
Acetaminophen
Drug-Induced Liver Injury
Pharmacogenetics
China
Case-Control Studies
candidate gene
Additional relevant MeSH terms:
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Chemical and Drug Induced Liver Injury
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning