The study is designed to collect safety and efficacy of Desferasirox in Chinese patients with Iron Overload and Aplastic Anemia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Initial Dose: 20 mg/kg/d. Dose modification according to protocol.
Novartis Investigative Site
Shanghai, Shanghai Municipality, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Beijing, China
Change in serum ferritin from baseline to 52 weeks with desferasirox treatment in Chinese patients with AA presenting with transfusional hemosiderosis and pre-existing serum ferritin levels of ≥ 1000 ng/mL.
Difference in serum ferritin from baseline vs. 52 weeks of treatment.
Time frame: Every 4 Weeks for 52 weeks of treatment
Correlation between serum ferritin (SF) and transferrin saturation (TFS)
Study will compare SF with TFS level to find degree of relationship measured by correlation.
Time frame: Every 4 Weeks for 52 weeks of treatment
Number of dispensed, used, partially used or unused packages of study medication to assess drug usage compliance
Time frame: Every 4 Weeks for 52 weeks of treatment
Correlation between dose adjustment (increase or decrease) regimens and transfusional burden
Evaluation of the relationship between dose adjustment regimens (as dictated by both efficacy and safety parameters) and transfusional burden will be undertaken.
Time frame: Every 3 months for 52 Weeks of treatment
Number of patients with adverse events, serious adverse events and death
Time frame: Every 4 weeks for 52 Weeks of treatment
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Novartis Investigative Site
Chengdu, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Tianjin, China