NCT00548860已完成3 期
A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum 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
- 2,018
- 试验地点
- 1
- 主要终点
- Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
研究概览
简要总结
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with iron deficiency anemia
- •Hg </= 11 g/dL
排除标准
- •Previous participation in a FCM trial
- •Known Hypersensitivity to FCM
- •History of anemia other that anemia due to heavy uterine bleeding or the post partum state
- •current history of GI bleeding
- •Received IV Iron within the month prior
- •Anticipated need for surgery
- •Malignancy history
- •AST or ALT greater than normal
- •Received an investigational drug within 30 days of screening
- •Pregnant or sexually active females who are not willing ot use an effective form of birth control
研究组 & 干预措施
Ferric Carboxymaltose (FCM)
Experimental
Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)
干预措施: Ferric Carboxymaltose (Drug)
Standard Medical Care (SMC)
Active Comparator
Varied as determined by the Investigator
干预措施: Standard Medical Care (SMC) (Drug)
结局指标
主要结局
Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
时间窗: From Day 0 through 30 days after the last dose of study drug.
Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).
次要结局
未报告次要终点
研究者
研究点 (1)
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