NCT02564094已完成4 期
Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Predictive value of reticulocyte increase
研究概览
简要总结
This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults at least 18 years of age
- •Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
- •Anemia with low erythropoeitin (EPO) levels
排除标准
- •Poorly controlled hypertension
- •Relevant acute or chronic bleeding requiring therapy within 3 months before study drug
- •Treatment with EPO within the last 6 weeks
- •Pregnant or breastfeeding females
研究组 & 干预措施
Epoetin beta
Experimental
Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.
干预措施: Epoetin beta (Drug)
结局指标
主要结局
Predictive value of reticulocyte increase
时间窗: At Week 2
Response rate according to hemoglobin level
时间窗: At Week 4
Transfusion requirement rate
时间窗: From Weeks 5 to 12
次要结局
- Incidence of adverse events (AEs)(Up to approximately 6 months)
研究者
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