Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

Conditions
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Postpartum Anemia

Intervention / Treatment
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* Drug: Ferric Carboxymaltose (FCM)
* Drug: Ferrous Sulfate tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Subjects able to give consent Post partum patients Baseline Hgb < /= 10 g/dL Agree to practice birth control Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric Carboxymaltose (FCM)<br>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. | Drug: Ferric Carboxymaltose (FCM)<br>* 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.<br>|
| Active Comparator: Ferrous Sulfate tablets<br>325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks. | Drug: Ferrous Sulfate tablets<br>* 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | anytime between baseline and end of study or time to intervention | 
| Reported Adverse Events |  | anytime between baseline and end of study or time to intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, postpartum