NCT06818916招募中不适用
Efficacy and Safety of Hetrombopag in Promoting Platelet Engraftment After Autologous Hematopoietic Stem Cell Transplantation in Children With Neuroblastoma
Beijing Children's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accumulated platelet engraftment rate
研究概览
简要总结
The goal of this clinical trial is to learn if hetrombopag promotes platelet engraftment in neuroblastoma children undergoing autologous hematopoietic stem cell transplantation. The main question it aims to answer is:
· Does drug hetrombopag promote platelet engraftment? Participants will take hetrombopag every day for 6 weeks or until platelet > 100*10^9/L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age<18 years old;
- •Diagnosed as neuroblastoma;
- •ECOG ≤ 2;
- •First time receiving autologous hematopoietic stem cell transplantation;
- •The subjects or their legal guardians agree to participate and sign the informed consent form.
排除标准
- •ALT/AST > 3 ULN, or TBIL > 1.5 ULN;
- •Have experienced congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication treatment within one year prior to enrollment, or have experienced myocardial infarction or cerebral infarction within three months prior to enrollment;
- •Suffering from thromboembolic diseases;
- •Other situations that are not suitable for inclusion in the study determined by researchers.
研究组 & 干预措施
Experimental group
Experimental
干预措施: Hetrombopag (Drug)
结局指标
主要结局
Accumulated platelet engraftment rate
时间窗: From enrollment to 60 days post-transplant
Platelet engraftment is defined as a continuous 7-day PLT ≥ 20 × 10\^9/L without platelet infusion.
次要结局
- Number of platelet transfusions(From enrollment to 60 days post-transplant)
- Time to platelet engraftment(From enrollment to 60 days post-transplant)
- Adverse events(From medication to 30 days after discontinuation)
- progression-free survival (PFS)(From enrollment to 60 days post-transplant)
研究者
Jun Yang
Beijing Children's Hospital
Beijing Children's Hospital
研究点 (1)
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