Phase 3
N=2,018
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00548860 ↗Enrolled (actual)
2,018
Serious AEs
1.4%
Results posted
May 2015
Primary outcome: Primary: Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. — 6; 22 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferric Carboxymaltose (Drug); Standard Medical Care (SMC) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- American Regent, Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. |
6; 22 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00548860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.