EUCTR2012-000650-64-GB进行中（未招募）1 期
An open label, multi-center, efficacy and safety study of deferasirox in iron overloaded patients with non-transfusion dependent thalassemia (THETIS) - THETIS
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
- 134
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)
- •Additional inclusion criteria as per full protocol may apply
- •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
- •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
- •Additional exclusion criteria as per full protocol may apply
研究者
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