EUCTR2007-004164-51-IT进行中（未招募）不适用
PI-Labile Plasma Iron in Deferasirox-Treated Thalassemic Patients - ND
FONDAZIONE ITALIANA LEONARDO GIAMBRONEPER LA GUARIGIONE DALLA TALASSEMIA - ONLUS0 个研究点开始时间: 2009年3月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •M/F >= 2 years of age Thalassemia Major or Intermedia regularly transfused Patients potentially eligible to the treatment with deferasirox History of at least 20 blood transfusions (equivalent to approximately 100 mL/kg of PRBC) or evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 µg/l); Serum ferritin could be <1,000 µg/l in patient effectively managed with other chelating therapies but for whom the physicians consider a change appropriate Written informed consent by the patient or by their parents or legal guardians on the patient?s behalf, and child?s or teenager?s assent (if applicable), in accordance with the national legislation. Female patients who have reached menarche and who are sexually active must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Non transfusional hemosiderosis Renal impairment and/or with estimated creatinine clearance <60 ml/min at baseline Clinically significant proteinuria Severe liver impairment and/or ALT/AST >500 U/L Pregnant or breast feeding patients Hypersensitivity to the active substance or to any of the excipients Concomitant use of other iron chelating agents Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline Patient unwilling or unable to comply with the protocol
研究者
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