Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment (NCT00447694) | Clinical Trial Compass
CompletedPhase 2
Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment
United States30 participantsStarted 2006-02
Plain-language summary
The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2\* in beta-thalassemia patients with deferasirox treatment.
Who can participate
Age range10 Years
SexALL
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Inclusion Criteria:
* Male or female β-thalassemia outpatients on chronic transfusion therapy (defined as \> 8 transfusions per year)
* Lifetime minimum of 100 previous packed red blood cell transfusions
* Patients currently on chelation therapy will require a one day wash out prior to the first dose of study drug
* Age ≥ 10 years
* Sexually active females of childbearing potential must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy.
Exclusion Criteria:
* Ejection Fraction \< 56 % measured using steady-state free precession imaging by MRI
* Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia
* Abnormal laboratory values as defined by the protocol
* Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
* History of HIV positive test result (ELISA or Western blot)
* Uncontrolled systemic hypertension
* Second or third degree A-V block
* Life-threatening arrhythmias, including sustained ventricular tachycardia and aborted sudden death, within the last year
* History of cardiac conditions or unstable cardiac disease not controlled by standard medical therapy
* History of clinically relevant ocular toxicity related to iron chelation
* Systemic diseases (ca…
What they're measuring
1
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2*