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

Inclusion Criteria

• 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).
• Hgb <11 g/dL
• Ferritin ≤300 ng/mL and TSAT <30%

Exclusion Criteria

• Known history of hypersensitivity reaction to any component of FCM.
• History of acquired iron overload, hemochromatosis, or other iron accumulation disorders.
• 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.
• Any existing non-viral infection.
• Known history of positive HBsAg or HCV with evidence of active hepatitis.
• Known history of positive HIV-1/HIV-2 antibodies (anti-HIV).
• Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin B12 or folic acid deficiency) that has not been corrected.
• Administration and / or use of an investigational product (drug or device) within 30 days of screening.
• Alcohol or drug abuse within the past six months.
• 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.
• Unable to comply with study procedures and assessments.