Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years

Completed · Phase 3

Conditions studied: Anemia, Iron-deficiency

In brief

The objective of the study is to compare the safety and gastrointestinal tolerability of ferric maltol oral suspension and ferrous sulfate oral liquid in children and adolescents aged 2 years to 17 years, and assess the safety and tolerability of ferric maltol oral suspension in children 1 month to less than 2 years, in the treatment of iron deficiency anaemia during the 12 weeks treatment period.

Key facts

Study ID: NCT05126901
Run by: Shield Therapeutics
People needed: 65
Starts: 2021-11-03
Expected to finish: 2024-06-09
Last updated by the study team: 2025-11-10

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is willing and able to comply with the study requirements and to provide written informed consent. In the case of patients under the age of legal consent, the legal guardian(s) must provide informed consent and the patient should provide assent per local and national requirements.
Age ≥1 month and ≤17 years at the time of informed consent
Subjects must have iron deficiency anaemia defined by the following criteria, as measured by the central laboratory at the screening visit
Haemoglobin thresholds define anaemia by age and gender:
Children (1 m - < 5 yrs) <11.0 g/dl Children (5 yrs - < 12 yrs) <11.5 g/dl Children (12 yrs) <12.0 g/dl Female child (≥13 yrs) <12.0 g/dl Male child (≥13 yrs) <13.0 g/dl and
Ferritin thresholds define anaemia by:
ferritin <30 µg/L, or ferritin <50 µg/L with transferrin saturation (TSAT) <20%, 4. Female subjects of childbearing potential must agree to use a highly effective method of contraception (which includes complete abstinence) until study completion and for at least 4 weeks following their final study visit. Highly effective contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), a vasectomised partner and oral contraceptive medications.
The need for contraception and compliance with contraception requirements will be assessed at every visit for adolescent patients, and urine pregnancy testing will be performed at each visit for female subjects of childbearing potential.

You may not qualify if…

Subject with anaemia due to any cause other than iron deficiency, including, but not limited to,
a. Untreated or untreatable severe malabsorption syndrome
Subjects who have received prior to Screening:
Within 28 days intramuscular or intravenous (IV) injection or administration of depot iron preparation.
Within 7 days single agent iron preparations and during the study.
Within 12 weeks of blood transfusion or is scheduled to have blood transfusion or donation during the study period
Within 28 days erythropoiesis stimulating agents and during the study period
Within 14 days COVID-19 vaccination
Subjects with vitamin B12 or folic acid deficiency as determined by the central laboratory screening results. Subjects may start vitamin B12 or folate replacement and rescreen after at least 2 weeks.
Has concomitant disease that would significantly compromise iron absorption or absorbed iron utilization such as swallowing disorders and/or extensive small bowel resection.
History of active peptic ulcer
Has chronic renal disease (eGFR <60 mL/min/m2), as assessed at Screening based on serum creatinine.
Known hypersensitivity or allergy to either the active substance or excipients of ferric maltol or ferrous sulfate.
Has a known contraindication for treatment with iron preparations, e.g. haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassemia, or lead intoxication induced anaemia.
Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate transaminase (AST)>2.0 times upper normal limit as measured at the Screening visit.
Active acute inflammatory disease, including IBD flare or disease exacerbation, which in the opinion of the Investigator, is clinically significant.
Active chronic or acute infectious diseases requiring antibiotic treatment.
Pregnant or breast feeding.
Concomitant medical conditions with extensive active bleeding, other than menstrual cycles; subjects who suffer from menorrhagia may be included at the Investigator's discretion.
Scheduled or expected hospitalisation and/or surgery during the course of the study
Participation in any other interventional clinical study within 28 days prior to Screening.
Diagnosed to be COVID-19 positive by (SARS-CoV-2-RT-PCR positive) within 28 days prior to screening.
Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal, immunologic, endocrine, metabolic, respiratory or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or objectives of the study drug or severely limit the lifespan of the subject.
Any other unspecified reason that, in the opinion of the Investigator or the Sponsor make the subject unsuitable for enrolment.

Where it is running

The Center for Clinical Trials — Saraland, Alabama, United States
Homestead Research Institute — Homestead, Florida, United States
Kissimmee Clinical Research Corp — Kissimmee, Florida, United States
Miami Clinical Research — Miami, Florida, United States
Medical Research of Westcheste — Miami, Florida, United States
Eminent Clinical Research and Associates — North Lauderdale, Florida, United States
Clinical Research Prime — Idaho Falls, Idaho, United States
Sierra Clinical Research — Las Vegas, Nevada, United States
Levine Cancer Institute — Charlotte, North Carolina, United States
Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
Hasbro Children's Hospital — Providence, Rhode Island, United States
BRCR Global Texas — Edinburg, Texas, United States
Zion Research — Katy, Texas, United States
MultiCare Health System Institute for Research and Innovation — Tacoma, Washington, United States
BRCR Global Puerto — San Juan, Puerto Rico
Noah's Ark Children's Hospital for Wales — Cardiff, United Kingdom
Royal Hospital for Sick Children - Edinburgh — Edinburgh, United Kingdom
Leicester Royal Infirmary — Leicester, United Kingdom
Alder Hey Children's NHS Foundation Trust — Liverpool, United Kingdom
King's College Hospital — London, United Kingdom
Newham University Hospital — London, United Kingdom
Royal Manchester Children's Hospital — Manchester, United Kingdom
Nottingham University Hospitals — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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