NCT04269707

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a single arm, open-label, multi-center, multi-national, non-randomized study that will evaluate the efficacy and safety of a one course treatment with FCM in participants who had an unsatisfactory response to oral iron in study 1VIT17044. Subjects will have an End of Study (EOS) Visit (Day 35) from the 1VIT17044 study to qualify for entry. Subjects will then be screened, meet all inclusion criteria, no exclusion criteria and have a baseline evaluation. Based on the successful completion of the baseline evaluations, subjects will be enrolled and will receive the first dose of FCM (Day 0). The second FCM dose will occur 7 days from the first dose. Subjects will return to the clinic 14 and 28 days post their first dose for laboratory and safety assessments, and at 35 days post the first dose, participants will return to the clinic for final safety and efficacy assessments. Once all assessments are complete the participant will exit the study. An unsatisfactory response to oral iron (i.e., an increase in hemoglobin (Hgb) of \<1 g/dL from baseline) will be defined as non-responders to oral iron treatment. Non-responders who continue to meet all inclusion criteria (including Hgb \<11 g/dL) and none of the exclusion criteria will receive 1 course of FCM.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose	IV iron

Timeline

• Start date: 2019-11-19
• Primary completion: 2020-12-30
• Completion: 2021-01-29
• First posted: 2020-02-17
• Last updated: 2022-03-21
• Results posted: 2022-03-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study