Phase 3
N=289
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Postpartum Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00354484 ↗Enrolled (actual)
289
Serious AEs
2.8%
Results posted
Dec 2013
Primary outcome: Primary: 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 — 127; 98 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferric Carboxymaltose (FCM) (Drug); Ferrous Sulfate tablets (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- American Regent, Inc.
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
127; 98 | — |
| PRIMARY Reported Adverse Events |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00354484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.