NCT07214025尚未招募不适用
Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Durable Platelet Response in Patients Receiving Treatment for Chronic ITP
研究概览
简要总结
The aim is to evaluate safety and efficacy of Romiplostim in the treatment of chronic ITP in children
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 1 and 18 years
- •Diagnosis of chronic ITP
- •Refractory to or intolerant of first-line therapies (e.g.corticosteroids , intravenous immunoglobulin [ IVIG ] , and oral eltrombopag )
- •Platelet count<30,000/µL, or evidence of bleeding or risk of bleeding with platelet count<50,000/µL.
- •Written informed consent (or parental/guardian consent for minors)
排除标准
- •Evidence of secondary thrombocytopenia (e.g., HIV, HCV, systemic lupus erythematosus)
- •congenital thrombocytopenia
- •Age < 1year or more than 18 years
- •Aplastic anemia
- •Known hypersensitivity to romiplostim or any of its components
结局指标
主要结局
Durable Platelet Response in Patients Receiving Treatment for Chronic ITP
时间窗: Up to 48 weeks of treatment
The proportion of patients achieving a durable platelet response, defined as platelet counts ≥50 × 10⁹/L for at least 6 of the final 8 weeks of a 48-week treatment period, without the need for rescue therapy (e.g., IVIG, corticosteroids, platelet transfusion).
次要结局
- Time to Initial Platelet Response(Up to 48 weeks of treatment.)
- Need for Rescue Medications(Up to 48 weeks of treatment.)
- Rate of Treatment-Free Remission(Up to 48 weeks of treatment.)
研究者
Mostafa Refat Mostafa Ali
Principal Investigator
Assiut University
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