EUCTR2012-000650-64-IT进行中（未招募）不适用
An open label, multi-center, efficacy and safety study of deferasirox in iron overloaded patients with nontransfusion dependent thalassemia.(THETIS) - THETIS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Male or female aged = 10 years with non-transfusion-dependent congenital or chronic anemias inclusive of beta-thalassemia intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease) • LIC = 5 mg Fe/g dw measured by R2 MRI at screening • Serum ferritin = 300 ng/mL at screening (two consecutive values at least 14 days apart from each other) • Written informed consent obtained prior to any screening procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 17
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •HbS-beta Thalassemia • Anticipated regular transfusion program during the study • Any blood transfusion 6 months prior to study start • Significant proteinuria; creatinine clearance =40 ml/min; serum creatinine >ULN; ALT >5xULN
研究者
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