NCT04102033Unknown4 期
Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 主要终点
- Measuring the platelet count response to eltrombopag in pediatric chronic ITP
研究概览
简要总结
This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with chronic ITP aged 1 to 17 years.
- •Platelet count is less than 30×109 per liter.
- •Patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or IV immunoglobulin.
排除标准
- •Patients with clinical and/or laboratory evidence of hepatotoxicity/liver decompensation (Hepatotoxicity due to eltrombopag is defined as increased serum alanine aminotransferase ≥3 times the upper limit of normal (ULN), aspartate aminotransferase ≥3 ULN, alkaline phosphatase >1.5 ULN, total bilirubin >1.5 ULN)
- •Patients with history of thrombotic/thromboembolic events.
结局指标
主要结局
Measuring the platelet count response to eltrombopag in pediatric chronic ITP
时间窗: 6 months
次要结局
未报告次要终点
研究者
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