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

NCT00354484 | Completed Phase 3 Results

• 1 other identifier: 1VIT06011
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Anemia

Keywords

anemia; postpartum

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Ferric Carboxymaltose (FCM)

EXPERIMENTAL

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.

Drug: Ferric Carboxymaltose (FCM)

Ferrous Sulfate tablets

ACTIVE COMPARATOR

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

Drug: Ferrous Sulfate tablets

Interventions

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.

Ferric Carboxymaltose (FCM)

Ferrous Sulfate tablets DRUG

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

Ferrous Sulfate tablets

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female Subjects able to give consent
• Post partum patients
• Baseline Hgb \< /= 10 g/dL
• Agree to practice birth control

You may not qualify if:

• 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

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Location

Related Publications (6)

• 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.

  PMID: 17666600 RESULT

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

  RESULT

• 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.

  PMID: 18928998 RESULT

• 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.

  RESULT

• 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.

  RESULT

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

  RESULT

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@luitpold.com

610-650-4200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 20, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: February 20, 2018
• Results First Posted: December 5, 2013

Record last verified: 2018-01

Locations

US (1)