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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.

Tracking Information
First Submitted Date  ICMJE July 13, 2006
First Posted Date  ICMJE July 20, 2006
Results First Submitted Date  ICMJE October 8, 2013
Results First Posted Date  ICMJE December 5, 2013
Last Update Posted Date February 20, 2018
Study Start Date  ICMJE May 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: July 17, 2006)
  • Number of patients classified as a clinical success
  • Reported Adverse Events
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Anemia
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2013)
291
Original Enrollment  ICMJE
 (submitted: July 17, 2006)
320
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00354484
Other Study ID Numbers  ICMJE 1VIT06011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party American Regent, Inc.
Study Sponsor  ICMJE American Regent, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account American Regent, Inc.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP