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

Postpartum Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354484
• Other study ID #: 1VIT06011
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2006
• Last updated: January 22, 2018
• Start date: May 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Postpartum Anemia

Intervention

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.
• Ferrous Sulfate tablets
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (7)

Goodnough LT. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: a Randomized Controlled Study. Nordic Conference of Obstetrics & Gynecology 2008.

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 — View 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.

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.

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.

Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: A Randomized Controlled Study. Southern Medical Association Scientific Assembly 2008.

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. Erratum in: Obstet Gynecol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Reported Adverse Events		anytime between baseline and end of study or time to intervention