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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
Not Enrolling
Both
Iron Deficiency Anemia

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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