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

NCT04269707 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 1VIT18045
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin From Baseline to Day 35

  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 Hgb from baseline to day 35

Study Arms (1)

IV Iron

OTHER

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.

Drug: Ferric carboxymaltose

Interventions

Ferric carboxymaltose DRUG

IV iron

IV Iron

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.
• Alcohol or drug abuse within the past six months.
• 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 precautions during the study.
• Unable to comply with study procedures and assessments.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (2)

Miami Clinical Research

Miami, Florida, 33155, United States

Location

South Florida Research Phase I-IV

Miami Springs, Florida, 33166, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: American Regent, Inc.

mfalone@americanregent.com

631.772.3544

Study Officials

• Mark Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: November 19, 2019
• Primary Completion: December 30, 2020
• Study Completion: January 29, 2021
• Last Updated: March 21, 2022
• Results First Posted: March 21, 2022

Record last verified: 2022-03

Locations

US (2)