Status:
TERMINATED
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
Lead Sponsor:
IBSA Institut Biochimique SA
Collaborating Sponsors:
Cromsource
Conditions:
Congenital Hypothyroidism
Eligibility:
All Genders
1-9 years
Phase:
PHASE4
Brief 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...
Detailed Description
Newly diagnosed neonates will be randomly assigned to start therapy with LT4 at the initial dose recommended by the Standard of Care (SOC). Infants already on LT4 therapy will continue at the same dai...
Eligibility Criteria
Inclusion
- Male and female patient aged 0 to 9 months
- Primary CH diagnosis with elevated TSH and low or normal FT4, requiring treatment with LT4, under either of the following conditions:
- Neonates newly diagnosed with primary CH and needing to initiate LT4 therapy, or
- Infants previously diagnosed with primary CH and who are already on LT4 therapy for at least 3 weeks;
- Provide and comply with the informed consent.
Exclusion
- Preterm neonates with a gestational age \< 37 weeks;
- Low birth weight (LBW) or very low birth weight (VLBW) neonates (weight \< 2.5 kg) or VLBW infants (weight \< 1.5 kg);
- Neonates in neonatal intensive care units or requiring admission to NICU or neonates/infants hospitalized or requiring hospitalization or in fragile health conditions (e.g. with serious health problems or complications);
- Neonates with CH diagnosis \> 4 weeks after delivery;
- Diagnosis of primary gastrointestinal disease:
- Gastroesophageal reflux requiring medical therapy (beyond thickening of formula or position);
- Anatomic defects (e.g. intestinal atresia, malrotation, tracheoesophageal fistula, pyloric stenosis, Hirschsprung's disease, gastroschisis);
- Dietary allergy (e.g. cow's milk protein allergy);
- Malabsorption related to cystic fibrosis, celiac disease and others;
- Necrotizing enterocolitis requiring surgical resection;
- Known or suspected adrenal insufficiency (e.g. congenital adrenal hyperplasia, hypopituitarism);
- Diagnosis of congenital cardiac disease, cardiac insufficiency or risk for cardiac failure;
- Diagnosis of chromosomopathy;
- Diagnosis of central hypothyroidism;
- Hypersensitivity to glycerol;
- Concomitant anticonvulsant medications, liothyronine, combination of LT4 and liothyronine, thyroid extracts and/or chronic or long-term use of systemic glucocorticoids
- History of nonadherence with medication or medical visit schedule; or
- Any condition for which, participation would not be in the best interest of the patient or that could limit protocol specified assessments.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05228184
Start Date
January 21 2022
End Date
March 27 2025
Last Update
October 23 2025
Active Locations (10)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
CHOC Children's Hospital
Orange, California, United States, 92868
3
University of California San Francisco
San Francisco, California, United States, 94143
4
Yale University
New Haven, Connecticut, United States, 06511