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

January 22, 2018 updated by: American Regent, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

361

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19403
        • Luitpold Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Ferrous Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
anytime between baseline and the end of study or time to intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Regent, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

November 2, 2006

First Submitted That Met QC Criteria

November 3, 2006

First Posted (Estimate)

November 6, 2006

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1VIT03001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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