NCT02076412已完成3 期
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 35
- 主要终点
- Number of Participants With Stable Platelet Response of at Least 50,000/µL
研究概览
简要总结
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of persistent/chronic ITP for at least 3 months
- •Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts
排除标准
- •Clinical diagnosis of autoimmune hemolytic anemia
- •Uncontrolled or poorly controlled hypertension
- •History of coagulopathy including prothrombotic conditions
研究组 & 干预措施
Fostamatinib Disodium
Experimental
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
干预措施: Fostamatinib Disodium (Drug)
Placebo
Other
Placebo tablet PO bid (morning and evening) over the course of 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Stable Platelet Response of at Least 50,000/µL
时间窗: Baseline to Week 24
Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24
次要结局
- Number of Participants With Platelet Count ≥ 50,000/µL at Week 12(Baseline to Week 12)
- Number of Participants With Platelet Count ≥ 50,000/µL at Week 24(Baseline to Week 24)
- Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12(Baseline to Week 12)
- Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24(Baseline to Week 24)
- Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS)(Baseline to Week 24)
- Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale(Baseline to Week 24)
研究者
研究点 (35)
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