Back to resultsSafety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Primary Purpose
Postpartum Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose (FCM)
Ferrous Sulfate tablets
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Anemia focused on measuring anemia, postpartum
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
Sites / Locations
- Luitpold Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferric Carboxymaltose (FCM)
Ferrous Sulfate tablets
Arm Description
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.
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
Outcomes
Primary Outcome Measures
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
Reported Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354484
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Anemia
Keywords
anemia, postpartum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Ferrous Sulfate tablets
Arm Type
Active Comparator
Arm Description
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Intervention Description
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 Type
Drug
Intervention Name(s)
Ferrous Sulfate tablets
Intervention Description
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
Primary Outcome Measure Information:
Title
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
Title
Reported Adverse Events
Time Frame
anytime between baseline and end of study or time to intervention
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Luitpold Pharmaceuticals
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17666600
Citation
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. doi: 10.1097/01.AOG.0000275286.03283.18. Erratum In: Obstet Gynecol. 2008 Apr;111(4):996.
Results Reference
result
Citation
Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: A Randomized Controlled Study. Southern Medical Association Scientific Assembly 2008.
Results Reference
result
PubMed Identifier
18928998
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
Goodnough LT. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: a Randomized Controlled Study. Nordic Conference of Obstetrics & Gynecology 2008.
Results Reference
result
Learn more about this trial
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
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