A single-arm interventional Phase IV, post-authorisation study evaluating the safety of pediatric patients withtransfusional hemosiderosis treated with deferasirox crushed film coated tablets

ovartis Pharma AG0 个研究点目标入组 44 人开始时间: 2017年10月17日最近更新: 2020年7月13日

研究概览

暂无简介。

•oPatients =2 to <6 years old diagnosed with transfusional hemosiderosis
•oDocumented history of red blood cell transfusions
•oWritten informed consent/assent before any study-specific procedures.
•oFor patients on prior DFX: Serum ferritin (SF) >500 ng/mL, measured at screening visit 1 and requiring a DFX daily dose equivalent to FCT = 7mg/kg/day.
•oFor patients on a prior chelator other than DFX (e.g. deferiprone or deferaxamine) or chelation naive: Serum ferritin (SF) >1000 ng/mL measured at screening visits 1 and 2
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•oHistory of hypersensitivity to any of the study drug or excipients.
•oSerum creatinine > age adjusted ULN measured at any screening visit
•oCreatinine clearance below 90 mL/minute measured at any screening visit.
•oALT and/or AST > 2.5 x ULN measured at screening visit 1.
•oTotal bilirubin (TBIL) >1.5 x ULN measured at screening visit 1.
•oPatients with significant impaired GI function or GI disease that may significantly alter the absorption of oral deferasirox FCT (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
•oPatients unwilling or unable to comply with the protocol

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