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