A Phase 3 Open Label Extension 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
- 123
- 试验地点
- 55
- 主要终点
- Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Fostamatinib in 047/048 or 049):Version 1
研究概览
简要总结
The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response.
- •Able and willing to give written informed consent
排除标准
- •Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response
- •Poorly controlled hypertension during Study C935788-047 or Study C935788-048
- •Significant infection, an acute infection such as influenza, or known inflammatory process
研究组 & 干预措施
Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
干预措施: Fostamatinib Disodium (Drug)
结局指标
主要结局
Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Fostamatinib in 047/048 or 049):Version 1
时间窗: Up to 12 months
Percentage of subjects who achieved platelet count of at least 50,000/µL within 12 Weeks of beginning treatment up to 12 months was analyzed among all subjects who received active treatment in one of the prior studies (C788-047 or C788-048), in the current extension study (C788-049), or in both prior and current studies. Treated Population was defined as all enrolled and treated subjects.
Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Placebo in 047/048 and Fostamatinib 049): Version 2
时间窗: Up to 12 months
A within-subject, between-study comparison of platelet counts for subjects who were previously treated with placebo in one of the prior studies (C788-047 or C788-048) was prospectively defined in the protocol (version 2). Achievement of platelet response by 12 weeks and maintenance of platelet response for 12 weeks was analyzed among subjects who had been randomized to placebo in one of the prior studies (C788-047 or C788-048). Treated Population was defined as all enrolled and treated subjects.
次要结局
- Duration of Platelet Response Based on Platelet Count and Rescue Medication(Up to 12 months)
- Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count(Up to 12 months)