A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 52
- 主要终点
- Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24)
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
Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability.
干预措施: Fostamatinib disodium (Drug)
Placebo
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 (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24)
时间窗: From Week 14 to Week 24
A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24
次要结局
- Number of Participants With Platelet Count ≥ 50,000/µL at Week 12(Week 12)
- Number of Participants With Platelet Count ≥ 50,000/µL at Week 24(Week 24)
- Mean of the ITP Bleeding Score (IBLS)(Assessed over the 24-week study period)
- Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12.(Baseline to Week 12)
- Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24.(Baseline to Week 24)
- Mean of World Health Organization (WHO) Bleeding Scale(Assessed over the 24-week study period)