NCT00144495已完成3 期
A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- The increase in Hb concentration
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients
排除标准
- •a history of myocardial, cerebral or pulmonary infarction
- •severe hypertension beyond control by drugs
研究组 & 干预措施
1
Experimental
patient whose ΔHb is less than 1.0g/dL on the day of 7th administration
干预措施: recombinant human erythropoietin (Drug)
2
Experimental
patient whose ΔHb is 1.0g/dL or above on the day of 7th administration
干预措施: recombinant human erythropoietin (Drug)
结局指标
主要结局
The increase in Hb concentration
时间窗: Day 28th or later
次要结局
- Changes in QOL scores(84 days)
研究者
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