FORTIS
Research type
Research Study
Full title
Randomised, open-label, active-controlled, multicentre, comparative study to evaluate the safety and efficacy of ferric maltol (iron(III)-maltol complex) (ST10) oral suspension compared to ferrous sulfate oral liquid in children and adolescents aged 2 to 17 years with iron-deficiency anaemia, incorporating a single arm study in infants aged 1 month to less than 2 years
IRAS ID
1003968
Contact name
Minal Kara
Contact email
Sponsor organisation
Shield TX (UK) Ltd.
Eudract number
2018-000078-31
Research summary
Research Summary:
The purpose of this study is to compare a new medicine, ferric maltol in a liquid form, with ferrous sulfate to find out which is better for treating iron‐deficiency anaemia in children and adolescents. The study will have different age groups from 1 month to 17 years old.
For children over 2 years old, the study will assess how effective ferric maltol is, how it makes them feel, and look at any side effects, compared to ferrous sulfate. Under 2 years olds will only receive ferric maltol to assess how safe and effective it is at treating iron‐deficiency anaemia.
Ferric maltol is currently available in a capsule format and has been approved to treat iron deficiency/iron deficiency anaemia as a prescription only medication.
Ferrous sulphate is a medicine that is already available for the treatment of iron‐deficiency anaemia.
Approximately 110 children and adolescents will take part in this study at approximately 20 study sites in 2 countries. The study will include 98 people aged 2 to 17 years old and up to 12 infants aged at least one month but less than 2 years.
The study will last approximately 16 weeks and include up to 8 study visits to the study site and up to 1 phone call.
Shield Tx is sponsoring this study.Summary of results:
Following approval by ethics committees and regulatory authorities, the ST10-01-305 study took place between November 2021 and June 2024 at 23 research sites in UK, and USA (including Puerto Rico). 56 patients (aged 1 month to 17 years) with iron deficiency anaemia completed this phase 3 study.
The study intended to compare the safety and tolerability of ferric maltol oral suspension and ferrous sulphate oral liquid in children and adolescents aged 2 to 17 years, and to assess the safety and tolerability of ferric maltol oral suspension in children aged 1 month to less than 2 years, in the treatment of iron deficiency anaemia. The study also intended to assess the effect on haemoglobin in children and adolescents aged 1 month to 17 years after receiving twice daily ferric maltol oral suspension.
Overall, ferric maltol was well tolerated in patients and there was a meaningful change in haemoglobin. Palatability was considered similar and/or more favourable for patients receiving ferric maltol compared to those receiving ferrous sulphate.
The study confirmed that ferric maltol oral suspension improved iron storage levels and was well tolerated in children/adolescents from 1 month to 17 years using the dosages used in the study.https://clinicaltrials.gov/study/NCT05126901?tab=results
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0200
Date of REC Opinion
26 Oct 2021
REC opinion
Further Information Favourable Opinion