NCT02599012Unknown2 期
The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with Hemoglobin response
研究概览
简要总结
- Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
- Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
- Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
- In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.
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
- •Subjects who diagnosed with solid cancer or lymphoma
- •Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment
- •anticancer therapy: "chemotherapy", and/or "chemotherapy + radiotherapy", and/or "target agent"
- •Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment
排除标准
- •Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment
- •Subjects with uncontrolled infection
- •Subjects with ongoing bleeding
- •Deteriorated organ function
- •poor performance state (ECOG 3-4)
- •Subjects whose disease involves bone marrow
- •Ferritin > 800 ng/ml and Transferrin saturation(TSAT) ≥ 50%
研究组 & 干预措施
Subjects
Experimental
干预措施: Ferinject® (Drug)
结局指标
主要结局
Number of participants with Hemoglobin response
时间窗: visit 4th after Ferinject injection
次要结局
未报告次要终点
研究者
Jun Ho Jang
Professor
Samsung Medical Center
研究点 (1)
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