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

Phase 3

Completed

• Conditions: Postpartum Anemia
• Interventions: Drug: Ferric Carboxymaltose (FCM); Drug: Ferrous Sulfate tablets

• Registration Number: NCT00354484
• Lead Sponsor: American Regent, Inc.

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-20
• Primary Completion: 2006-12
• Study Completion: 2007-01
• Results First Submitted: 2013-10-08
• Results First Submitted QC: 2013-10-08
• Results First Posted: 2013-12-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 291

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferric Carboxymaltose (FCM)	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.
Ferrous Sulfate tablets	Ferrous Sulfate tablets	325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

Primary Outcome Measures

Name	Time	Method
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	anytime between baseline and end of study or time to intervention
Reported Adverse Events	anytime between baseline and end of study or time to intervention

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States