Trial Outcomes & Findings for Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044 (NCT NCT04269707)

Last Updated: 2022-03-21

Results Overview

The change in hemoglobin from Baseline to Day 35 was assessed using paired t-tests (two-sided test, α = 0.05). Baseline hemoglobin was defined as the last hemoglobin obtained before the first dose.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

7 participants

Primary outcome timeframe

The change in Hgb from baseline to day 35

Results posted on

2022-03-21

Participant Flow

1VIT17044, NCT03523117 can be referenced to make the information accessible.

Participant milestones

Participant milestones
Measure	IV Iron The primary objective in this study is to allow participants who were randomized to receive oral iron in the 1VIT17044 trial and who had an 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 \[Day 0 thru Day 35 of study protocol 1VIT17044, NCT03523117 can be referenced to make the information accessible.\], change in IBD treatment) to receive one course of FCM. This course of FCM will consist of two doses of FCM at 15 mg/kg (maximum single dose of 750 mg), separated by seven days. Ferric carboxymaltose: IV iron
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Iron n=7 Participants The primary objective in this study is to allow participants who were randomized to receive oral iron in the 1VIT17044 trial and who had an 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) to receive one course of FCM. This course of FCM will consist of two doses of FCM at 15 mg/kg (maximum single dose of 750 mg), separated by seven days. Ferric carboxymaltose: IV iron
Age, Customized Age	7 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: The change in Hgb from baseline to day 35

Population: The change in hemoglobin from Baseline to Day 35 was assessed using paired t-tests (two-sided test, α = 0.05). Baseline hemoglobin was defined as the last hemoglobin obtained before the first dose.

The change in hemoglobin from Baseline to Day 35 was assessed using paired t-tests (two-sided test, α = 0.05). Baseline hemoglobin was defined as the last hemoglobin obtained before the first dose.

Outcome measures

Outcome measures
Measure	IV Iron n=7 Participants The primary objective in this study is to allow participants who were randomized to receive oral iron in the 1VIT17044 trial and who had an 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) to receive one course of FCM. This course of FCM will consist of two doses of FCM at 15 mg/kg (maximum single dose of 750 mg), separated by seven days. Ferric carboxymaltose: IV iron
Change in Hemoglobin From Baseline to Day 35	0.70 g/dL Interval -0.4 to 1.8

Adverse Events

IV Iron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark A. Falone, MD

American Regent, Inc.

Phone: 631.772.3544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place