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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Standard Medical Care (SMC); Drug: Ferric Carboxymaltose

• Registration Number: NCT00548860
• Lead Sponsor: American Regent, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-24
• Primary Completion: 2009-03
• Study Completion: 2009-07
• Results First Submitted: 2013-10-08
• Results First Submitted QC: 2015-05-11
• Results First Posted: 2015-05-29
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2018

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Medical Care (SMC)	Standard Medical Care (SMC)	Varied as determined by the Investigator
Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose	Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)

Primary Outcome Measures

Name	Time	Method
Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.	From Day 0 through 30 days after the last dose of study drug.	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).

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States