Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

January 22, 2018 updated by: American Regent, Inc.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.

Study Type

Interventional

Enrollment (Actual)

291

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female Subjects able to give consent
  • Post partum patients
  • Baseline Hgb < /= 10 g/dL
  • Agree to practice birth control

Exclusion Criteria:

  • Participation in previous clinical trial of this investigational agent
  • Known hypersensitivity reaction to active control
  • Significant vaginal bleeding
  • History of anemia other than iron deficiency anemia
  • Anticipated need for surgery during the study
  • Active severe infection or malignancy
  • Known positive Hepatitis B antigen of Hepatitis C viral antibody
  • Known HIV antibodies
  • Received an investigational drug within 30 days of screening
  • Alcohol abuse within past 6 months
  • Hemochromatosis or other iron storage disorders
  • Significant cardiovascular disease
  • Any laboratory abnormality, medical condition or severe psychiatric disorder which in the opinion of the investigator woud put the subject's disease management at risk or may result in the subject being able to comply with the study requirements

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ferric Carboxymaltose (FCM)
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
Drug: Ferric Carboxymaltose (FCM)
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
ACTIVE_COMPARATOR: Ferrous Sulfate tablets
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
Drug: Ferrous Sulfate tablets
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL
Time Frame: anytime between baseline and end of study or time to intervention
anytime between baseline and end of study or time to intervention
Reported Adverse Events
Time Frame: anytime between baseline and end of study or time to intervention
anytime between baseline and 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

May 1, 2006

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (ESTIMATE)

July 20, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 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

  • 1VIT06011

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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