EUCTR2016-002583-14-Outside-EU/EEA进行中（未招募）1 期
A Randomized, Open-label, Multi-center, Phase II Study to Evaluate the Safety and Efficacy of Deferasirox (ICL670) 20 mg/kg/Day Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients With Iron Overload From Repeated Blood Transfusions - Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease
ovartis Pharmaceuticals Corp0 个研究点目标入组 210 人开始时间: 2016年11月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •Age greater than or equal to 2 years
- •Male or female patients with sickle cell disease (SS, SC, SD, Sßo or Sß+ thalassemia)
- •Iron overload from repeated blood transfusion
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 203
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 77
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Serum creatinine above the upper limit of normal
- •Significant proteinuria•History of nephrotic syndrome
- •Alanine aminotransferase (ALT) = 250 U/L at screening
- •Clinical evidence of active hepatitis B or hepatitis C
研究者
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