Phase 3 Completed N=352 Randomized Treatment

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

Anemia

Source: ClinicalTrials.gov NCT00396292 ↗

Enrolled (actual)

352

Serious AEs

2.3%

Results posted

Dec 2013

Primary outcomePrimary: Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin — 162; 159 participants

Summary

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin	162; 159	—

Eligibility Criteria

Inclusion Criteria

Female Subjects able to give consent
Post partum patients
Baseline Hbg< /= 10
Agree to practice birth control
Demonstrate willingness to comply with protocol restrictions

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00396292). 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. Informational only — not medical advice.