EUCTR2011-004217-17-Outside-EU/EEA进行中（未招募）不适用
A single-arm, open-label study of the Palatability and Tolerability of Exjade Taken with Meals, with Different Liquids or Crushed and Added to Food
ovartis Pharmaceuticals Corporation0 个研究点目标入组 65 人开始时间: 2011年12月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
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
- •1.Male or female patients with thalassemia major, sickle cell disease (SCD), low or intermediate 1 (INT 1) risk myelodysplastic syndrome (MDS) or other anemias and transfusional hemosiderosis.
- •2.Patients who were on, starting, or resuming treatment with Exjade.
- •3.Patients who were >2 years (i.e., 2 years of age or older).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1.Serum creatinine above the upper limit of normal (ULN) for age.
- •2.Alanine aminotransferase (ALT) >2.5 times the ULN.
- •3.High risk intermediate-2 or high risk MDS or acute leukemia.
研究者
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