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NCT05126901 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study, sponsored by Shield Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
NCT05126901: Completed Phase 3 study, sponsored by Shield Therapeutics.
NCT05126901 is a Phase 3 study that has completed, run by Shield Therapeutics. The registered enrollment target is 65 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05126901, a Phase 3 study, has completed, sponsored by Shield Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
Study 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.
Primary Outcome
The change in Hb concentration from baseline to Week 12 is summarized based on the mITT Population for each treatment group using descriptive statistics summarized by mean, standard deviation, median, and range (minimum and maximum). The Randomized/ITT Population is defined as all patients who were randomized/assigned to treatment arms. The mITT Population is defined as all patients in the ITT Population who received at least 1 treatment dose.
Interventions
- DRUG Ferrous sulfate
- DRUG Ferric Maltol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2024-06-09 |
| Phase | Phase 3 |
What the finished NCT05126901 record still lists
NCT05126901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Ferrous sulfate is the first listed.
NCT05126901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05126901 about?
NCT05126901 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05126901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2021-11-03. Estimated completion is 2024-06-09.
What interventions are being tested in trial NCT05126901?
The interventions under investigation include: Ferrous sulfate (DRUG), Ferric Maltol (DRUG).
Who is sponsoring clinical trial NCT05126901?
This trial is sponsored by Shield Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05126901's enrollment target sits among peer trials
65 1797th of 2000 higher than 202 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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