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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 is a Phase 4 study that was terminated before completion, run by IBSA Institut Biochimique. The registered enrollment target is 34 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05228184
The ClinicalTrials.gov registry entry for NCT05228184 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IBSA Institut Biochimique, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Levothyroxine Sodium is the first listed.
NCT05228184 reports 0 study locations.
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.
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