Iron Deficiency Anemia (IDA) MedDRA version: 20.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Injectafer
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
American Regent, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants 1 to 17 years of age with assent to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the Independent Review Board / Ethics Committee. 2. Screening Hgb =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity reaction to any component of FCM. 2. Previous randomization and treatment in this study or any other clinical study of FCM. 3. History of acquired iron overload, hemochromatosis, or other iron accumulation disorders. 4. History of significant diseases of the liver, hematopoietic system, cardiovascular system, psychiatric disorder, or other conditions which, on the opinion of the investigator, may place a subject at added risk for participation in the study. 5. Any existing non-viral infection. 6. Known history of positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis. 7. Known history of positive HIV-1/HIV-2 antibodies (anti-HIV). 8. Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin B12 or folic acid deficiency) that has not been corrected. 9. Intravenous iron and /or blood transfusion in the 4 weeks prior to consent. 10. Administration and / or use of an investigational product (drug or device) within 30 days of screening. 11. Alcohol or drug abuse within the past six months. 12. Female participant who is pregnant or lactating, or sexually active female who are of childbearing potential not willing to use an acceptable form of contraceptive precautions during the study. 13. Unable to comply with study procedures and assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy and safety of intravenous (IV) ferric carboxymaltose (FCM), compared to oral iron,;Secondary Objective: Not applicable;Primary end point(s): The change in hemoglobin from baseline to day 35 will be summarized separately for the following subgroups: • Cause of IDA: IBD, not IBD • CKD, not CKD • Baseline hemoglobin : <10, =10 g/dL • Age: 1 to <12, =12 to 17 years ;Timepoint(s) of evaluation of this end point: from baseline to Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in ferritin from baseline to Day 35 2. Change in TSAT from baseline to Day 35 3. Changes from baseline in hemoglobin, ferritin, TSAT, and reticulocyte hemoglobin content throughout the study. 4. Pharmacokinetic assessments, including Cmax, Tmax, AUC0-time last measured concentration, AUC0-infinity, T1/2, MRT, Cl, VD, VDc, VDss, and VDarea. These assessments will be based on a population pharmacokinetic analysis using data from this study and 1VIT13036.;Timepoint(s) of evaluation of this end point: Accordingly: 1. from baseline to Day 35 2. from baseline to Day 35 3. throughout the study. 4. Pre-dose, post-dose, 60 minutes post-dose | — |
Countries
Canada, Poland, Ukraine, United States
Contacts
Public ContactClinical Trial Information
American Regent, Inc.
Outcome results
None listed