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.

Tracking Information

• First Submitted Date: July 13, 2006
• First Posted Date: July 20, 2006
• Results First Submitted Date: October 8, 2013
• Results First Posted Date: December 5, 2013
• Last Update Posted Date: February 20, 2018
• Study Start Date: May 2006
• Actual Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 8, 2013)

• 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 ]
• Reported Adverse Events [ Time Frame: anytime between baseline and end of study or time to intervention ]

Original Primary Outcome Measures (submitted: July 17, 2006)

• Number of patients classified as a clinical success
• Reported Adverse Events

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: July 17, 2006): Time to clinical success designation
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
• Official Title: Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
• 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.
• 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
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Postpartum Anemia

Intervention

• 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.
• Drug: Ferrous Sulfate tablets
  325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

Study Arms

• 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.
  Intervention: Drug: Ferric Carboxymaltose (FCM)
• Active Comparator: Ferrous Sulfate tablets
  325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
  Intervention: Drug: Ferrous Sulfate tablets

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 8, 2013): 291
• Original Enrollment (submitted: July 17, 2006): 320
• Actual Study Completion Date: January 2007
• Actual Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00354484
• Other Study ID Numbers: 1VIT06011
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: American Regent, Inc.
• Study Sponsor: American Regent, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: American Regent, Inc.
• Verification Date: January 2018