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

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.

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Key information

Conditions

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ferric carboxymaltose

Drug

Standard Medical Care (SMC)

Drug

Primary outcomes

Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.

Time frame: 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).

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Oct 24, 2007
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.

Published trials that share one or more normalized conditions with this study.

Completed