Pharmacogenetic Study in Patients Received Iron Chelating Agent

Completed

• Conditions: Hemosiderosis

• Registration Number: NCT01623895
• Lead Sponsor: Seoul National University Hospital

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 Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-17
• Study First Posted: 2012-06-20
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients who received deferasirox because of transfusion associated iron overload (Transfusion associated iron overload was defined as ferritin ≥ 1,000 ng/mL in patients who needed over 8 units of RBC transfusions per a year).
2. Patients with written informed consents

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Exclusion Criteria

Patients or parents refusal

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic polymorphism associated with side effects of deferasirox	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of