Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

Anemia Clinical Trial

Official title:

A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548860
• Other study ID #: 1VIT07017
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2007
• Last updated: January 22, 2018
• Start date: October 2007
• Est. completion date: July 2009

Study information

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

Clinical Trial Summary

The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2018
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female with iron deficiency anemia

• Hg </= 11 g/dL

Exclusion Criteria:

• Previous participation in a FCM trial

• Known Hypersensitivity to FCM

• History of anemia other that anemia due to heavy uterine bleeding or the post partum state

• current history of GI bleeding

• Received IV Iron within the month prior

• Anticipated need for surgery

• Malignancy history

• AST or ALT greater than normal

• Received an investigational drug within 30 days of screening

• Pregnant or sexually active females who are not willing ot use an effective form of birth control

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Uterine Hemorrhage

Intervention

Drug:
• Ferric Carboxymaltose

• Standard Medical Care (SMC)

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.	Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).	From Day 0 through 30 days after the last dose of study drug.