Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid… (NCT05126901) | Clinical Trial Compass
CompletedPhase 3
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
United States65 participantsStarted 2021-11-03
Plain-language 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.
Who can participate
Age range1 Month – 17 Years
SexALL
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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
Exclusion criteria
✕. Subject with anaemia due to any cause other than iron deficiency, including, but not limited to,
✕. 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.