drugset / Trial / NCT04968379

Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia

NCT04968379

Phase 2 Withdrawn American Regent, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

An Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Ferric Carboxymaltose (FCM) in Infants (0-1 year) with Iron Deficiency Anemia.

Timeline

Start
2022-07-21
Primary completion
2024-10-08
Completion
2024-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 5 mg/kg Intravenous
Subject Ferric carboxymaltose Other / unclassified 7.5 mg/kg Intravenous