A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Iron Deficiency Anemia
Both
Iron Deficiency Anemia
Trial Information
A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
Inclusion Criteria
Key Inclusion Criteria include:
1. Subjects who completed participation in study AMAG-FER-IDA-301
2. Female subjects of childbearing potential who are sexually active must be on an
effective method of birth control and agree to remain on birth control until
completion of participation in the study
Key Exclusion Criteria include:
1. Experienced a serious adverse event (SAE) related to ferumoxytol in study
AMAG-FER-IDA-301
2. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, or
have a positive serum/urine pregnancy test
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Hemoglobin changes
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
AMAG-FER-IDA-303
NCT ID:
NCT01114217
Start Date:
July 2010
Completion Date:
May 2013
Related Keywords:
- Iron Deficiency Anemia
- Iron deficiency anemia
- Feraheme
- ferumoxytol
- AUB
- cancer
- GI disorders
- postpartum anemia
- The treatment of iron deficiency anemia (IDA)
- Anemia
- Deficiency Diseases
- Anemia, Iron-Deficiency
Name | Location |
|---|---|
| AMAG Pharmaceutcials, Inc. | Lexington, Massachusetts 02421 |
