NCT02612558已完成2 期
A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 36
- 主要终点
- Hemoglobin response
研究概览
简要总结
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Subject must have had a diagnosis of primary or secondary warm antibody AIHA.
- •Must have failed at least 1 prior treatment regimen for AIHA.
排除标准
- •Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.
- •Subject with a platelet count of < 30,000/μL.
- •Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
- •Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
研究组 & 干预措施
Fostamatinib 150 mg
Experimental
Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
干预措施: Fostamatinib 150 mg bid (Drug)
结局指标
主要结局
Hemoglobin response
时间窗: by Week 24
Hemoglobin level of \> 10 g/dL and 2 g/dL higher than the baseline hemoglobin
次要结局
未报告次要终点
研究者
研究点 (36)
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