Pharmacogenetic Study in Patients Received Iron Chelating Agent

Hemosiderosis Clinical Trial

Official title:

Pharmacogenetic Study in Patients Received Iron Chelating Agent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623895
• Other study ID #: SNUCH-R-0701
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: July 11, 2014
• Start date: December 2007
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemosiderosis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Chongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic polymorphism associated with side effects of deferasirox	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	up to 1 year	No