A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 37
- 主要终点
- Blood Pressure
研究概览
简要总结
The primary objective of this study is:
• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
- •Subject must have completed all 24 weeks of participation in the study C-935788-057.
排除标准
- •Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
研究组 & 干预措施
Fostamatinib
Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study.
All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment.
干预措施: Fostamatinib disodium (Drug)
结局指标
主要结局
Blood Pressure
时间窗: 104 weeks
Change from baseline in blood pressure over time
Absolute Neutrophil Count (ANC)
时间窗: 104 weeks
Change from baseline in absolute neutrophil count (ANC) over time
Adverse Events
时间窗: 104 weeks
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
次要结局
- Achievement of Durable Hemoglobin Response(24 weeks)
- Total Duration of Response(During the Intervention period up to 104 weeks)
- Corticosteroid dose(During the Intervention period up to 104 weeks)