Pharmacogenetic Study in Patients Received Iron Chelating Agent

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01623895

Enrollment

100

Registered

2012-06-20

Start date

2007-12-31

Completion date

2013-06-30

Last updated

2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemosiderosis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

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

Exclusion criteria

Patients or parents refusal

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results