Phase 3
N=65
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
Anemia · Iron-deficiency
Bottom Line
View on ClinicalTrials.gov: NCT05126901 ↗Enrolled (actual)
65
Serious AEs
1.6%
Results posted
Nov 2025
Primary outcome: Primary: Change in Hemoglobin Concentration — 17.7; 12.5; 11.5 g/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferric Maltol (Drug); Ferrous sulfate (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Shield Therapeutics
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin Concentration |
17.7; 12.5; 11.5 | — |
| SECONDARY Changes in Ferritin Concentration |
6.3; 8.1; 20.6 | — |
| SECONDARY Change in Iron Concentration |
1.07; 5.77; 3.64 | — |
| SECONDARY Change in the Percentage of Transferrin Saturation |
2.0; 7.7; 6.5 | — |
| SECONDARY Cmax for Plasma Maltol Glucuronide |
4350; 6810; 6420; 4250; 5940; 8160 | — |
| SECONDARY Tmax for Plasma Maltol Glucuronide |
1.00; 2.13; 0.52; 0.98; 2.78; 3.63 | — |
| SECONDARY AUC0-t for Plasma Maltol Glucuronide |
7670; 12000; 14600; 5900; 8070; 16700 | — |
| SECONDARY Cmax for Baseline Corrected Serum Iron |
87.0; 40.0; 119; 96.5; 21.0; 364 | — |
| SECONDARY Tmax for Baseline Corrected Serum Iron |
2.37; 2.13; 2.00; 2.10; 2.78; 6.63 | — |
| SECONDARY AUC0-t for Baseline Corrected Serum Iron |
64.4; 60.1; 374; 100; 1.93; 1180 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 - 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.
Data sourced from ClinicalTrials.gov (NCT05126901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.