EUCTR2019-003821-70-PL
Active, not recruiting
Phase 1
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
DrugsInjectafer®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- American Regent, Inc.
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<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
Outcomes
Primary Outcomes
Not specified
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