NCT00628043已完成3 期
A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
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
- 160
- 试验地点
- 6
- 主要终点
- The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
研究概览
简要总结
This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing 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
- Triple (Participant, Care Provider, Investigator)
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
- •Lung cancer or gynecologic cancer patients
- •Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
- •8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
- •20 - 79 years old
- •Performance status: 0 - 2
- •No iron deficiency anemia
排除标准
- •Red blood cell transfusion within 4 weeks before treatment
- •Erythropoietin therapy within 8 weeks before treatment
研究组 & 干预措施
EPOCH
Experimental
干预措施: epoetin beta (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
时间窗: 16 weeks
次要结局
- Change in FACT- total Fatigue Subscale score (FSS)(16 weeks)
- Requirement for RBC transfusion(16 weeks)
- Change in Hb(16 weeks)
研究者
研究点 (6)
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