Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients with Iron Deficiency Anemia

Phase 1

• Conditions: Iron Deficiency Anemia (IDA); MedDRA version: 20.0Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2019-003821-70-PL
• Lead Sponsor: American Regent, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-28
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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 <11 g/dL
3. Ferritin =300 ng/dL and Transferrin Saturation (TSAT) <30%
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified