Overview

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044

Status:
Completed
Trial end date:
2021-01-29
Target enrollment:
0
Participant gender:
All
Summary
Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol 1VIT17044
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
American Regent, Inc.
Treatments:
Ferric Compounds
Iron
Criteria
Inclusion Criteria:

1. Unsatisfactory response to oral iron or those that required a concomitant
intervention, (defined as, blood transfusion, use of IV or oral iron outside of
protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study
protocol 1VIT17044], change in IBD treatment).

2. Hgb <11 g/dL

3. Ferritin ≤300 ng/mL and TSAT <30%

Exclusion Criteria:

1. Known history of hypersensitivity reaction to any component of FCM.

2. History of acquired iron overload, hemochromatosis, or other iron accumulation
disorders.

3. History of significant diseases of the liver, hematopoietic system, cardiovascular
system, psychiatric disorder, or other conditions which, in the opinion of the
investigator, may place a subject at added risk for participation in the study.

4. Any existing non-viral infection.

5. Known history of positive HBsAg or HCV with evidence of active hepatitis.

6. Known history of positive HIV-1/HIV-2 antibodies (anti-HIV).

7. Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin
B12 or folic acid deficiency) that has not been corrected.

8. Administration and / or use of an investigational product (drug or device) within 30
days of screening.

9. Alcohol or drug abuse within the past six months.

10. Female participant who is pregnant or lactating, or sexually active females who are of
childbearing potential not willing to use an acceptable form of contraceptive
precautions during the study.

11. Unable to comply with study procedures and assessments.