Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
Age
10–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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 (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
Pregnancy or breast feeding (documented negative pregnancy test required for study entry)
Patients enrolled in an ongoing clinical trial of deferasirox (ICL670) cannot be withdrawn in order to participate in this study
Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
