Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)

Stopped early · Phase 4

Conditions studied: Congenital Hypothyroidism

In brief

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).

Key facts

Study ID

NCT05228184

Run by

IBSA Institut Biochimique SA

People needed

34

Starts

2022-01-21

Expected to finish

2025-03-27

Last updated by the study team

2026-06-26

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• CHOC Children's Hospital — Orange, California, United States
• University of California San Francisco — San Francisco, California, United States
• Yale University — New Haven, Connecticut, United States
• Children's Hospital of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
• Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cook Children's Health Care Systems — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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