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Pharmacogenetic Study in Patients Received Iron Chelating Agent

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01623895
Collaborator
(none)
100
Enrollment
1
Location
66
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Pharmacogenetic Study in Patients Received Iron Chelating Agent
    Study Start Date :
    Dec 1, 2007
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Chongno-gu Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyoung Jin Kang, MD. Ph D., Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01623895
    Other Study ID Numbers:
    • SNUCH-R-0701
    First Posted:
    Jun 20, 2012
    Last Update Posted:
    Jul 14, 2014
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Hemochromatosis
    Hemosiderosis

    Study Results

    No Results Posted as of Jul 14, 2014