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An open label trial evaluating cardiac T2* in -thalassemia patients on deferasirox (Exjade, ICL670) treatment for 18 months

Dr. Paul Harmatz is the principal investigator of this study to evaluate changes in cardiac iron as measured by MRI T2* over 18 months in patients with -thalassemia with evidence of cardiac iron overload and normal cardiac function.

Who can participate?

    Inclusion Criteria
  • Patients who are chronically transfused
  • Patients who are over the age of 10 years
    Exclusion Criteria
  • Patients who are pregnant
  • Patients who are ineligible for an MRI or SQUID due to incompatible metal implant(s), pacemaker, orthodontics (braces), claustrophobia
  • Patients with cardiac disease
  • Patients who have certain other diseases or conditions

What does the study involve?

  • Patients will have screening tests to see if they qualify for the study. These tests include:
  • T2 Star/cardiac MRI
  • SQUID (liver iron assessment)
  • Echocardiogram and EKG
  • Eye examination
  • Physical examination
  • Blood and urine tests
  • Patients who qualify for the study will be given Exjade, starting at a dose of 30 mg/kg, to take daily for 18 months.
  • Patients will have blood and urine testing done every four weeks and will be asked about any changes to their health and medicines. Whenever possible, these visits will be done at the same time as a regularly scheduled clinic or Day Hospital appointments.
  • Every six months, patients will repeat the heart MRI, SQUID, EKG, and echocardiogram.
  • The study will reimburse $25 for each completed study visit.

For more information, please contact Jacqueline Madden at Children's Hospital & Research Center at Oakland, 510-428-3885, ext. 5745 or ask your clinical care provider.


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