Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.
详细描述
This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.
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 Hgb < /= 10 g/dL
- •Agree to practice birth control
排除标准
- •Participation in previous clinical trial of this investigational agent
- •Known hypersensitivity reaction to active control
- •Significant vaginal bleeding
- •History of anemia other than iron deficiency anemia
- •Anticipated need for surgery during the study
- •Active severe infection or malignancy
- •Known positive Hepatitis B antigen of Hepatitis C viral antibody
- •Known HIV antibodies
- •Received an investigational drug within 30 days of screening
- •Alcohol abuse within past 6 months
- •Hemochromatosis or other iron storage disorders
- •Significant cardiovascular disease
- •Any laboratory abnormality, medical condition or severe psychiatric disorder which in the opinion of the investigator woud put the subject's disease management at risk or may result in the subject being able to comply with the study requirements
研究组 & 干预措施
Ferric Carboxymaltose (FCM)
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
干预措施: Ferric Carboxymaltose (FCM) (Drug)
Ferrous Sulfate tablets
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
干预措施: Ferrous Sulfate tablets (Drug)
结局指标
主要结局
Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL
时间窗: anytime between baseline and end of study or time to intervention
Reported Adverse Events
时间窗: anytime between baseline and end of study or time to intervention
次要结局
未报告次要终点