NCT02805153已完成4 期
The Multi-center, Open-label,Randomized Comparison Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.0 个研究点目标入组 215 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 主要终点
- the occurrence rate of grade IV neutropenia during the first chemotherapy cycle
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •diagnosis of breast cancer patients
- •chemotherapy naive
- •Karnofsky Performance Status ≥ 70
- •Written informed consent are acquired
排除标准
- •uncontrolled infection
- •Have accepted radiotherapy within 4 weeks before anticipated the study
- •pregnancy
- •Other situations that investigators consider as contra-indication for this study
研究组 & 干预措施
Experimental/PEG-rhG-CSF
Experimental
patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
干预措施: PEG-rhG-CSF (Drug)
Active Comparator/rhG-CSF
Active Comparator
patients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10^9/L was documented after the expected nadir, or for a maximum of 14 days
干预措施: rhG-CSF (Drug)
结局指标
主要结局
the occurrence rate of grade IV neutropenia during the first chemotherapy cycle
时间窗: through first cycle of chemotherapy,an average of 1 month
次要结局
- the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)(through the next three consecutive cycles chemotherapy,an average of 3 months)
- the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)(through the next three consecutive cycles chemotherapy,an average of 3 months)
研究者
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