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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Iron

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