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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Oral iron tablets; Drug: VIT-45

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396292

1VIT03001

Details and patient eligibility

About

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

Full description

This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Enrollment: 361 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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361 participants in 2 patient groups

VIT-45

Experimental group

Description:

A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered

Treatment:

Drug: VIT-45

Oral iron tablets

Active Comparator group

Description:

325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42

Treatment:

Drug: Oral iron tablets