Clinical Trial: A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Clinical Study to Evaluate the Effect of Glutathion S-transferase Polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Amoxicillin/Clavulanate and Explore Biomarkers fo
Brief Summary:
This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;
- To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate.
- To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.
Detailed Summary:
Sponsor: Seoul National University Hospital
Current Primary Outcome:
- Aspartate Aminotransferase (AST) [ Time Frame: 22 days ]
- Alanine Aminotransferase (ALT) [ Time Frame: 22 days ]
- Alkaline phosphatase (ALP) [ Time Frame: 22 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Seoul National University Hospital
Dates:
Date Received: January 18, 2014
Date Started: December 2013
Date Completion:
Last Updated: December 22, 2014
Last Verified: December 2014