NCT00224068已完成4 期
A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit® in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment
Watson Pharmaceuticals31 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2002年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 31
- 主要终点
- Change in hemoglobin
研究概览
简要总结
This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving 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
- 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
- •Diagnosis of nonmyeloid malignancy
- •Moderate to severe anemia
- •Adequate iron stores as measured by either TSAT or ferritin
- •About to start cycle of chemotherapy
- •Eligible for epoetin alfa therapy
排除标准
- •Highly elevated TSAT or ferritin
- •Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
- •Medical conditions that would confound the efficacy evaluation
结局指标
主要结局
Change in hemoglobin
次要结局
- Change in various iron indices
研究者
研究点 (31)
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