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NCT05228184 · ClinicalTrials.gov registry record · Phase 4
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
A Phase 4 study, sponsored by IBSA Institut Biochimique.
- Terminated
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT05228184: Clinical Trial Phase 4 study, sponsored by IBSA Institut Biochimique.
NCT05228184 is a Phase 4 study that was terminated before completion, run by IBSA Institut Biochimique. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05228184, a Phase 4 study, was terminated before completion, sponsored by IBSA Institut Biochimique.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH. Subjects will be randomized in a 2:1 ratio to Treatment (Tirosint®-SOL) or Control (conventional therapy with levothyroxine sodium crushed tablets).
Primary Outcome
The LT4 dose is calculated based on the daily LT4 dose (mcg) used in the time period preceding the visit (or the average daily dose on a weekly basis if more than one strength is used over the course of the week) and the body weight (kg) measured during the visit
Interventions
- DRUG Levothyroxine Sodium
- DRUG Tirosint®-SOL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-01-21 |
| Est. Completion | 2025-03-27 |
| Phase | Phase 4 |
Why NCT05228184 stopped before completion
NCT05228184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Levothyroxine Sodium is the first listed.
NCT05228184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05228184 about?
NCT05228184 is a clinical study titled "Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)". This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH. Subjects will be randomized in a 2:1 ratio to Treatment (Tirosint®-SOL) or Control (conventional therapy with levothyroxine sodium c...
What is the current status of trial NCT05228184?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2022-01-21. Estimated completion is 2025-03-27.
What interventions are being tested in trial NCT05228184?
The interventions under investigation include: Levothyroxine Sodium (DRUG), Tirosint®-SOL (DRUG).
Who is sponsoring clinical trial NCT05228184?
This trial is sponsored by IBSA Institut Biochimique, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05228184's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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