NCT05228184

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

A Randomized Comparative Study Between Liquid (Tirosint®-SOL) and Tablet Formulations of Levothyroxine in Neonates and Infants With Congenital Hypothyroidism

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: All
• Age: 1 Day – 9 Months
• Healthy volunteers: Not accepted

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).

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 daily dose within the randomly assigned treatment group (dose adjustments are allowed, if needed based on laboratory parameters and clinical response). Once enrolled, subjects will be treated and followed for 12 months (±1.5 months), participating in 7-8 study visits, consisting of 6-7 inclinic and 1-2 (or more if follow-up visits are required) telemedicine (TM) visits. The total number of visits depends on the age at inclusion.

Conditions

• Congenital Hypothyroidism

Interventions

Type	Name	Description
DRUG	Tirosint®-SOL	Dosage will be according to the USPI and Standard of Care.
DRUG	Levothyroxine Sodium	Tablets will be crushed and dissolved in solution. Dosage will be according to the USPI and Standard of Care.

Timeline

• Start date: 2022-01-21
• Primary completion: 2025-03-27
• Completion: 2025-03-27
• First posted: 2022-02-08
• Last updated: 2025-10-23

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study