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
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Condition or disease | Intervention/treatment |
---|---|
Acetaminophen Drug-Induced Liver Injury Pharmacogenetics China | Genetic: genetic polymorphism |
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 |
- genetic polymorphism [ Time Frame: 2 year ]the genetic polymorphism(HLA、SNPs )frequency difference between case and control groups
Biospecimen Retention: Samples With DNA
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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 |
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.
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
Contact: Hao Sun, professor | 13584017821 ext 86 | haosun@njmu.edu.cn |
China, Jiangsu | |
The First Affiliated Hospital with Nanjing Medical University | Recruiting |
Nanjing, Jiangsu, China | |
Contact: Jinghai Tang, professor 025-83284725 Jhtang305@126.com |
Study Chair: | Jingsong Zhang, professor | The First Affiliated Hospital with Nanjing Medical University |
Publications:
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 |
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 |
Acetaminophen Drug-Induced Liver Injury Pharmacogenetics |
China Case-Control Studies candidate gene |
Chemical and Drug Induced Liver Injury Liver Diseases Digestive System Diseases |
Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Poisoning |