CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 37 enrolled
Drug / intervention
Ferric Maltoldrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 10-17 years at informed consent and throughout study duration
  • ✓Current diagnosis of iron deficiency defined by ferritin <30 µg/L, or ferritin <50 µg/L with TSAT <20%
  • ✓Hemoglobin ≥8.5 g/dL at screening
  • ✓Willing and able to comply with study requirements
Key exclusion· 10
  • ✕Untreated or untreatable severe malabsorption syndrome, e.g., untreated coeliac disease
  • ✕Received intramuscular or IV depot iron preparation within 28 days prior to screening
  • ✕Received oral iron supplementation within 7 days prior to screening
  • ✕Received blood transfusion within 12 weeks prior to screening or scheduled for transfusion/donation during study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03181451
NCT03181451Phase 1Completed
CompareCT.gov

A Phase 1, Open-Label, Randomised, Repeat Dose, Parallel Group Study to Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects Aged 10-17 Years of Age With Iron Deficiency

Shield Therapeutics·interventional·Posted Jun 8, 2017·Updated Oct 6, 2021

In Brief

A Phase 1 clinical trial evaluating Ferric Maltol for Iron Deficiency, Anaemia in Children and Iron-Deficiency. Completed, enrolled 37 participants across 7 sites.

Detailed Summary

The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency, Anaemia in Children, Iron-Deficiency
CountriesUnited Kingdom
CollaboratorsMedpace, Inc.

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 8, 2017
Enrollment StartMar 14, 2017
Primary CompletionMar 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.1 years ago

Interventions

Ferric Maltoldrug

To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.