NCT03363334No Longer Available不适用
Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
C-935788-055 is an open-label, multi-center, expanded access (EAP) study.
详细描述
The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.
研究设计
- 研究类型
- Expanded Access
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
- •Adult patient with chronic or persistent ITP.
- •Must have failed or are unable to receive standard of care treatments for ITP.
- •Must have at least two platelet counts < 30,000/µL during the last 2 months prior to screen date.
排除标准
- •ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
- •Subject has uncontrolled or poorly controlled hypertension.
- •Any of the following laboratory abnormalities: neutrophil count of < 1,500/µL, or transaminase levels (ALT, AST) > 1.5x ULN, total bilirubin > 2.0 mg/dL.
- •Active HBV or HCV infection.
- •Current or recent enrollment in an investigational drug or device study.
研究者
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