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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00396292
Recruitment Status : Completed
First Posted : November 6, 2006
Results First Posted : December 10, 2013
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

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

Condition or disease Intervention/treatment Phase
Anemia Drug: Oral iron tablets Drug: VIT-45 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia
Study Start Date : February 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: 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

Active Comparator: 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
Drug: 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
Other Name: Ferrous Sulfate




Primary Outcome Measures :
  1. Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin [ Time Frame: anytime between baseline and the end of study or time to intervention ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396292


Locations
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United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
American Regent, Inc.

Publications of Results:
Baker JB, Seid MH, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Postpartum Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
Baker JB, Seid MH, Van Wyck DB, Dinh Q. Ferric Carboxymaltose, a New IV Iron Agent for Treating Postpartum Women with Iron Deficiency Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT00396292     History of Changes
Other Study ID Numbers: 1VIT03001
First Posted: November 6, 2006    Key Record Dates
Results First Posted: December 10, 2013
Last Update Posted: February 5, 2018
Last Verified: January 2018

Keywords provided by American Regent, Inc.:
Anemia
postpartum
Postpartum anemia

Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs