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®
Product Name: Injectafer®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/ml milligram(s)/mi
Sponsors
American Regent, Inc.
Eligibility
Sex/Gender
All
Inclusion 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 Inflammatory Bowel Disease [IBD] treatment). 2. 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. 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 hepatitis B surface antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis. 6. Known history of positive human immunodeficiency virus (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy and safety of intravenous (IV) ferric carboxymaltose (FCM) in pediatric participants who have iron deficiency anemia (IDA).;Secondary Objective: Not applicable;Primary end point(s): Change in Hgb from baseline to Day 35 ;Timepoint(s) of evaluation of this end point: from baseline to Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Change in ferritin from baseline to Day 35 ? Change in TSAT from baseline to Day 35 ? Changes from baseline in Hgb, ferritin, TSAT, and reticulocyte hemoglobin content (CHr) throughout the study;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. | — |
Countries
Poland, Ukraine
Contacts
Public ContactClinical Trial Information
American Regent, Inc.
Outcome results
None listed