NCT02767765已完成3 期
Pilot Study for Evaluating the Efficacy and Tolerability of Induction Therapy With Recombinant Human Erythropoietin Beta (rHuEPO) NeoRecormon® - at High Dose in Anemic Cancer Patients Treated With 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
- 61
- 主要终点
- Percentage of Participants With Response to Treatment
研究概览
简要总结
This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmed cancer
- •Participants who are treated with at least first line chemotherapy
- •Hemoglobin less than (<) 11 grams per deciliter (g/dL)
- •Participants able to receive iron supplement, if necessary
排除标准
- •History of hypersensitivity to active or inactive excipients of r-HuEPO
- •Insufficient controllable hypertension
- •Thalassemic syndromes
- •Anemia caused by hematic loss
- •Women who are pregnant or lactating
研究组 & 干预措施
r-HuEPO
Experimental
Anemic cancer participants will receive r-HuEPO for 4 weeks.
干预措施: r-HuEPO (Drug)
结局指标
主要结局
Percentage of Participants With Response to Treatment
时间窗: Week 4
Response to treatment was defined as an increase of greater than (\>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4.
次要结局
- Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4(Baseline, Week 4)
- Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment(Week 2)
- Time to Response(Baseline up to Week 4)
- Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment(Week 4)
- Percentage of Participants Who Required Transfusion(Baseline, Week 2, Week 4)
研究者
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