search
Back to results

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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oral iron tablets
VIT-45
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, postpartum, Postpartum anemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Luitpold Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VIT-45

Oral iron tablets

Arm 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

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

Outcomes

Primary Outcome Measures

Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin

Secondary Outcome Measures

Full Information

First Posted
November 2, 2006
Last Updated
January 22, 2018
Sponsor
American Regent, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00396292
Brief Title
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia
Official Title
Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, postpartum, Postpartum anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VIT-45
Arm Type
Experimental
Arm 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
Arm Title
Oral iron tablets
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Oral iron tablets
Other Intervention Name(s)
Ferrous Sulfate
Intervention 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
Intervention Type
Drug
Intervention Name(s)
VIT-45
Intervention 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
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Luitpold Pharmaceuticals
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
17666600
Citation
Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18. Erratum In: Obstet Gynecol. 2008 Apr;111(4):996.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs