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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: VIT-45; Drug: Oral iron tablets

• Registration Number: NCT00396292
• Lead Sponsor: American Regent, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-11
• Study Completion: 2006-02
• Study First Submitted: 2006-11-02
• Study First Submitted QC: 2006-11-03
• Study First Posted: 2006-11-06
• Results First Submitted: 2013-10-15
• Results First Submitted QC: 2013-10-15
• Results First Posted: 2013-12-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 361

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIT-45	VIT-45	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
Oral iron tablets	Oral iron tablets	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

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin	anytime between baseline and the end of study or time to intervention

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States