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

American Regent

Status and phase: Completed; Phase 3

Conditions: Postpartum Anemia

Treatments: Drug: Ferric Carboxymaltose (FCM); Drug: Ferrous Sulfate tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00354484

1VIT06011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 291 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 2 patient groups

Ferric Carboxymaltose (FCM)

Experimental group

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.

Treatment:

Drug: Ferric Carboxymaltose (FCM)

Ferrous Sulfate tablets

Active Comparator group

Description:

325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

Treatment:

Drug: Ferrous Sulfate tablets