Clinical Trial: Pharmacogenetic Study in Patients Received Iron Chelating Agent

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pharmacogenetic Study in Patients Received Iron Chelating Agent

Brief Summary: To investigate effect of genetic variations on the toxicities and find optimal target population, the investigators planned to analyze the genetic polymorphisms of UDP-glucuronosyltransferase.

Detailed Summary: Transfusion-associated iron overload induces systemic toxicity. Recently, deferasirox, a convenient long acting oral agent, has been introduced in clinical practice with promising efficacy. However, some patients experience drug-related toxicities and cannot tolerate it. To investigate effect of genetic variations on the toxicities and find optimal target population, we planned to analyze the genetic polymorphisms of UDP-glucuronosyltransferase 1A (UGT1A) subfamily, multi-drug resistance-associated protein 2 (MRP2) and breast cancer resistance protein (BCRP) among pediatric patients received deferasirox.
Sponsor: Seoul National University Hospital

Current Primary Outcome: Genetic polymorphism associated with side effects of deferasirox [ Time Frame: up to 1 year ]

Genetic polymorphism associated with side effects of deferasirox

- Side effects:

Increased AST or ALT > 5 x ULN or increased bilirubin > 3 x ULN which was thought to be caused by deferasirox Serum creatinine level increase > 50% above the baseline value.

  • Biospecimen Retention: Samples With DNA
  • Candidate genes exhibit polymorphisms and encodes proteins that are involved in the pharmacokinetics and pharmacodynamics of deferasirox.

Candidate genes : MRP2, BCRP, UGT1A subfamily



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Seoul National University Hospital

Dates:
Date Received: June 12, 2012
Date Started: December 2007
Date Completion:
Last Updated: July 11, 2014
Last Verified: December 2013