NCT00344409已完成3 期
A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- To compare the proportion of subjects who reach red blood cell transfusion trigger
研究概览
简要总结
To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as lung or gynecological cancer
- •patients receiving platinum containing chemotherapy
- •written informed consent
- •hemoglobin concentration less than 11 d/dL at enrollment
- •life expectancy of more than 4 months
排除标准
- •hemolysis, gastrointestinal bleeding, postoperative bleeding
- •iron deficiency
- •megaloblastic anemia
- •any primary hematological disorder that could cause anemia
- •received > 2 RBC transfusions with 4 weeks or any RBC transfusion within 2 weeks before randomization
- •prior treatment with KRN321
- •received erythropoetin therapy within 8 weeks before treatment
结局指标
主要结局
To compare the proportion of subjects who reach red blood cell transfusion trigger
次要结局
- To compare the effectiveness of KRN321 based on quality of life scores
- To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response
- To compare the proportion of subjects who receive red blood cell transfusions
研究者
研究点 (7)
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