Phase 3
N=352
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00396292 ↗Enrolled (actual)
352
Serious AEs
2.3%
Results posted
Dec 2013
Primary outcome: Primary: Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin — 162; 159 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oral iron tablets (Drug); VIT-45 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- American Regent, Inc.
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin |
162; 159 | — |
Summary
This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.
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
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.