CompletedPhase 3

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

United States7 participantsStarted 2019-11-19

Plain-language summary

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

Who can participate

Age range1 Year – 18 Years

SexALL

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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.

What they're measuring

Change in Hemoglobin From Baseline to Day 35

Timeframe: The change in Hgb from baseline to day 35

Trial details

NCT IDNCT04269707

SponsorAmerican Regent, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-30

Results submitted2021-11-02

View on ClinicalTrials.gov More Iron Deficiency Anemia trials