Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 361
- 试验地点
- 1
- 主要终点
- Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin
研究概览
简要总结
This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.
详细描述
This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.
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 Subjects able to give consent
- •Post partum patients
- •Baseline Hbg< /= 10
- •Agree to practice birth control
- •Demonstrate willingness to comply with protocol restrictions
排除标准
- •Known hypersensitivity reaction to oral or IV iron (VIT-45)
- •Documented history of discontinuing oral iron
- •Significant bleeding
- •History of anemia other that iron deficiency anemia
- •Severe Psychiatric disorders
- •Active severe infection
- •Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
- •Known HIV antibody
- •Received investigational product within 30 days
- •Alcohol abuse
- •Hemochromatosis or other iron storage disorder
研究组 & 干预措施
VIT-45
A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
干预措施: VIT-45 (Drug)
Oral iron tablets
325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
干预措施: Oral iron tablets (Drug)
结局指标
主要结局
Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin
时间窗: anytime between baseline and the end of study or time to intervention
次要结局
未报告次要终点