EUCTR2016-003482-25-IT进行中（未招募）1 期
A single-arm interventional Phase IV, post-authorisation study evaluating the safety of pediatric patients with transfusional hemosiderosis treated with deferasirox crushed film coated tablets -
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •o Patients =2 to <6 years old diagnosed with transfusional
- •hemosiderosis
- •o Documented history of red blood cell transfusions
- •o Written informed consent/assent before any study-specific
- •procedures.
- •o For 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.
- •o For 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:
- •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
排除标准
- •o History of hypersensitivity to any of the study drug or excipients.
- •o Serum creatinine > age adjusted ULN measured at any screening visit
- •o Creatinine clearance below 90 mL/minute measured at any screening visit.
- •o ALT and/or AST > 2.5 x ULN measured at screening visit 1.
- •o Total bilirubin (TBIL) >1.5 x ULN measured at screening visit 1.
- •o Patients 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).
- •o Patients unwilling or unable to comply with the protocol
研究者
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