Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
Reason given: Inability to recruit subjects
Key facts
- Where
- Atlanta, Boston, Chicago, Cincinnati, Fort Worth, Kansas City, Los Angeles, New Haven, Orange, and San Francisco, United StatesSee the 10 sites
- Phase
- Phase 4
Where in United States
- Children's Hospital of AtlantaAtlanta, United StatesNo longer taking part
- Boston Children's HospitalBoston, United StatesNo longer taking part
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesNo longer taking part
- Children's Hospital Medical CenterCincinnati, United StatesNo longer taking part
- Cook Children's Health Care SystemsFort Worth, United StatesNo longer taking part
- Children's Mercy Hospital and ClinicsKansas City, United StatesNo longer taking part
- Children's Hospital of Los AngelesLos Angeles, United StatesNo longer taking part
- Yale UniversityNew Haven, United StatesNo longer taking part
- CHOC Children's HospitalOrange, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
Trial details
- Who runs it
- IBSA Institut Biochimique SA
- Trial code
- NCT05228184
- Record updated
- 26 June 2026
- Original description
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.Read full original descriptionShow less
A Randomized Comparative Study Between Liquid (Tirosint®-SOL) and Tablet Formulations of Levothyroxine in Neonates and Infants With Congenital Hypothyroidism
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).
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: Concomitant anticonvulsant medications, liothyronine, combination of LT4 and liothyronine, thyroid extracts and/or chronic or long-term use of systemic glucocorticoids; 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); 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; Hypersensitivity to glycerol; 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; 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 with CH diagnosis > 4 weeks after delivery; Diagnosis of chromosomopathy; Diagnosis of central hypothyroidism.