NCT02905916Unknown4 期
The Efficacy and Safety of PEG-rhG-CSF in Neutropenia After Chemotherapy
Peking University1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Incidence of febrile neutropenia (FN)
研究概览
简要总结
The purpose of the trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age between 18 and 70 years.
- •Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients.
- •With multi-cycle chemotherapy.
- •With III/IV degree neutropenia after the last cycle of chemotherapy and plans to use the same regimen in the subsequent cycles.FN risk of the chemotherapy regimens is ≥20%，or 10%≤FN risk<20% and has high risk factors associated with FN.
- •Expected to survive more than 3 months.
- •No hematologic system disease and ANC≥1.5×10E9/L, PKT≥80×10E9/L, Hb≥ 75g/L, WBC≥3×10E9/L, and no bleeding tendency.
- •Written informed consent are acquired. -
排除标准
- •With infection or systemic antibiotic therapy 72h before chemotherapy.
- •With any abnormal hematopoietic function.
- •Received transplantation within 3 months.
- •Suffered from other malignant tumor or brain metastases.
- •TBIL, ALT,AST > 2.5×ULN; if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.
- •Cr >1.5 ×ULN.
- •Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
- •Mental or nervous system disorders.
- •Refused to accept contraceptive measures.
- •Other situations 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
Incidence of febrile neutropenia (FN)
时间窗: 30days after PEG-rhG-CSF administration
次要结局
未报告次要终点
研究者
Jun Zhu
Director
Peking University
研究点 (1)
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