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Completed

NCT Number: NCT00354484

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

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.

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Key information

Conditions

Postpartum Anemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferric Carboxymaltose (FCM)

Drug

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

Drug

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

Primary outcomes

  1. 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

  2. Reported Adverse Events

    Time frame: anytime between baseline and end of study or time to intervention

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Jul 20, 2006
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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