Trial · NCT05228184
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
NCT05228184, Phase 4, Terminated, IBSA Institut Biochimique SA
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH). Trials, record NCT05228184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05228184
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
- NCT number
- NCT05228184
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 34 participants, actual
- Lead sponsor
- IBSA Institut Biochimique SA
- Conditions
- Congenital Hypothyroidism
- Interventions
- Tirosint®-SOL, Levothyroxine Sodium
- First posted
- 2022-02-08
- Last updated
- 2026-06-26
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LT4 Dose Required to Maintain TSH in Target Range (Unit: mcg/kg/Day) | 1 year of age | 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 |
| Secondary | Hormonal Profile for TSH | 1 year of age | TSH (unit mIU/L) |
| Secondary | Hormonal Profile for FT4 | 1 year of age | FT4 (unit pmol/L) |
| Secondary | Frequency of Dose Adjustments | Up to 22 months based on age group | Percent number of subjects (%) who need a dose adjustment in the long-term follow up phase |
| Secondary | Number of Events of TSH Values Above 4.5 mU/L | Up to 22 months based on age group | TSH values above 4.5 mU/L |
| Secondary | Number of Events of FT4 Values Below the Middle of the Laboratory Normal Range | Up to 22 months based on age group | FT4 values below the middle of the laboratory normal range |
| Secondary | Growth Pattern for Length of Body | 1 year of age | Subject growth measurements in Length (cm) of body |
| Secondary | Growth Pattern for Body Weight | 1 year of age | Subject growth measurements in Body weight (kg) |
| Secondary | Growth Pattern for Head Circumference | 1 year of age | Subject growth measurements in Head circumference (cm) |
| Secondary | Parent/Caregiver Reports of Satisfaction and Ease of Administration | 3 weeks after treatment start | Parents Satisfaction Questionnaire is a study-specific tool measuring coping and mental well-being and satisfaction in 20 questions. 12 of these questions were scored from 1 to 5, with higher score meaning better outcome. Subject scores were calculated for each subject by visit as mean of the LN(single question score) \[min=0; max=1.61\]. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05228184
GET https://conductscience.org/api/trials/v1/NCT05228184/registered