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This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.
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Inclusion criteria
Additional Inclusion Criteria for Adult Patients:
Additional Inclusion Criteria for Pediatric Patients:
Exclusion criteria
Non-transfusional hemosiderosis
Patients with clinical evidence supporting the need for intensive chelation, based on the investigator's judgment
Patients with mean levels of alanine aminotransferase (ALT) > 300 U/l
Patients with uncontrolled systemic hypertension
Patients with serum creatinine above the upper limit of normal (ULN)
Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 (mg/mg) in second-voiding urine samples taken at both visits 1 and 2. A third sample is to be taken from patients in whom one ratio is > 0.5 (mg/mg) and one is ≤ 0.5 (mg/mg) and patients in whom the urinary protein/creatinine ratio is > 0.5 (mg/mg) in two of the three determinations are also to be excluded.
History of nephrotic syndrome
Patients with 3rd atrioventricular (A-V) block, clinically relevant Q-T interval prolongation as well as patients requiring treatment with digoxin and similar compounds or drugs which may induce prolongation of the Q-T interval
Patients with a previous history of clinically relevant ocular toxicity related to iron chelation
Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
Patients with psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing study treatment
Pregnant or breast feeding patients
Patients treated with systemic investigational drugs within the past 4 weeks or topical investigational drugs within the past 7 days
Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following:
History of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative
History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the run-in period
Patients with positive test to HIV
Life expectancy of < 1 year
Exclusion Criteria for Pediatric Patients:
Other protocol-defined inclusion/exclusion criteria may apply.
Primary purpose
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1,784 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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