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

• 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: American Regent, Inc.
• Information provided by (Responsible Party): American Regent, Inc.

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

United States, Pennsylvania

Luitpold Pharmaceuticals

Norristown, Pennsylvania, United States, 19403

Sponsors and Collaborators

American Regent, Inc.

More Information

Publications of Results:

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. Erratum in: Obstet Gynecol. 2008 Apr;111(4):996.

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, Derman RJ, Baker JB, Banach W, Goldberg C, Rogers R. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol. 2008 Oct;199(4):435.e1-7. doi: 10.1016/j.ajog.2008.07.046.

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.

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT00354484
• Other Study ID Numbers: 1VIT06011
• First Posted: July 20, 2006
• 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:

Anemia; Hematologic Diseases