A Phase 3, Open-label, Single-arm Study Evaluating the Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia Who Are Intolerant or Refractory to Current Cytoreductive Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 53
- 试验地点
- 19
- 主要终点
- Percentage of Subjects Who Responded in Platelet Count
研究概览
简要总结
The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10^9/L for at least 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy.
排除标准
- •Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with the study medication.
研究组 & 干预措施
Anagrelide Hydrochloride
干预措施: Anagrelide Hydrochloride (Drug)
结局指标
主要结局
Percentage of Subjects Who Responded in Platelet Count
时间窗: 12 months
A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
次要结局
- Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L(12 months)
- Percentage of Subjects With at Least 50% Reduction in Platelet Count(12 months)
- Percentage of Subjects With Normalization in Platelet Count(12 months)
- Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L(12 months)