Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
10–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Liver iron concentration ≥ 5 mg/g dry weight measured by Magnetic resonance imaging (MRI) before study start
Serum ferritin \>300 ng/mL at screening
Patients who completed the core CICL670A2209 clinical trial
Written informed consent obtained prior entry to one year extension study CICL670A2209
You may not be if
Hemoglobin S (HbS)-variants of thalassemia syndromes
Anticipated regular transfusion program during the study. Patients having a sporadic transfusion (e.g. in case of infection) throughout the study course will not be excluded
Any blood transfusion 6 months prior to study start
Creatinine clearance ≤ 60 mL/min at screening
Serum creatinine above the upper limit of normal at both screening visits
Significant proteinuria as indicated by a urine protein/urine creatinine ratio \> 1.0 mg/mg
Alanine aminotransferase (ALT) of \> 5 x the upper limit of normal at both screening visits
Concomitant therapy with hydroxyurea, erythropoietin, butyrate
History of deferasirox treatment
Pediatric patients: a patient's weight of below 20 kg
Patients with a continuous increase in serum creatinine ≥ 33% above the baseline value and \> ULN who did not improve after drug interruption or dose reduction in the core study
Patients with a continuous increase in ALT greater than 2 times the baseline value and \> 5 times ULN who did not improve after drug interruption or dose reduction in the core study
Patients with progressive proteinuria, as assessed by the investigator, who did not improve after drug interruption or dose reduction in the core study
Significant medical condition interfering with the ability to partake in this study (e.g.systemic uncontrolled hypertension, unstable cardiac disease not controlled by standard medical therapy, systemic disease (cardiovascular, renal, hepatic, etc.)
Clareo Health | Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study
