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

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: NCT00354484
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : December 5, 2013
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postpartum Anemia Drug: Ferric Carboxymaltose (FCM) Drug: Ferrous Sulfate tablets Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Study Start Date : May 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Reported Adverse Events [ Time Frame: anytime between baseline and end of study or time to intervention ]

Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT00354484


Locations
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United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
American Regent, Inc.
More Information
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Publications of Results:
Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: A Randomized Controlled Study. Southern Medical Association Scientific Assembly 2008.
Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose in a Randomized Controlled Study. American Journal of Obstetrics & Gynecology S26, 2007.
Seid MH, Rogers R, Dinh Q. The Safety and Tolerability of Ferric Carboxymaltose in Treating Postpartum Women with Iron Dediciency Anemia. American College of Obstetrics & Gynecology District Meeting 2007.
Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Managment 6th Annual Meeting 2007.
Goodnough LT. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: a Randomized Controlled Study. Nordic Conference of Obstetrics & Gynecology 2008.

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Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT00354484    
Other Study ID Numbers: 1VIT06011
First Posted: July 20, 2006    Key Record Dates
Results First Posted: December 5, 2013
Last Update Posted: February 20, 2018
Last Verified: January 2018
Keywords provided by American Regent, Inc.:
anemia
postpartum
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases