NCT02953730已完成4 期
The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- area under the curve(AUC)
研究概览
简要总结
The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≤18 years old, gender no limited.
- •Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
- •Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
- •Previously not received radiotherapy.
- •Karnofsky Performance Scores ( KPS)≥
- •The expected survival time was >3 months.
- •Neutropenia or agranulocytosis, no bleeding tendency.
- •No significant cardiac dysfunction or metabolic disease.
- •TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） < 2.5×ULN（upper limit of normal）.
- •BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）<1.5×ULN.
- •Written informed consent are acquired.
排除标准
- •With a history of systemic radiotherapy.
- •Infection difficult to control, the body temperature ≥ 38℃.
- •Other situation that investigators consider as contra-indication for this study.
研究组 & 干预措施
PEG-rhG-CSF
Experimental
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
area under the curve(AUC)
时间窗: 1 year
elimination half life(t 1/2kel)
时间窗: 1 year
peak concentration(Cmax)
时间窗: 1 year
次要结局
未报告次要终点
研究者
Xiaofan Zhu
chief physician
Chinese Academy of Medical Sciences
研究点 (1)
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