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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose
Standard Medical Care (SMC)
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Luitpold Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferric Carboxymaltose (FCM)

Standard Medical Care (SMC)

Arm Description

Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)

Varied as determined by the Investigator

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 22, 2007
Last Updated
January 22, 2018
Sponsor
American Regent, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00548860
Brief Title
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2018 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)
Arm Title
Standard Medical Care (SMC)
Arm Type
Active Comparator
Arm Description
Varied as determined by the Investigator
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose
Intervention Type
Drug
Intervention Name(s)
Standard Medical Care (SMC)
Primary Outcome Measure Information:
Title
Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
Description
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).
Time Frame
From Day 0 through 30 days after the last dose of study drug.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Luitpold Pharmaceuticals
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28487769
Citation
Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13.
Results Reference
derived

Learn more about this trial

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

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