drugset
drugset / Trial / NCT05228184

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

NCT05228184 ↗

Phase 4 Terminated 34 enrolled IBSA Institut Biochimique SA Cromsource · collab
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2022-01-21
Primary completion
2025-03-27
Completion
2025-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Levothyroxine Other / unclassified 13 ug Oral
Subject Levothyroxine Other / unclassified 25 ug Oral
Subject Levothyroxine Other / unclassified 37.5 ug Oral
Subject Levothyroxine Other / unclassified 44 ug Oral
Subject Levothyroxine Other / unclassified 50 ug Oral
Subject Levothyroxine Other / unclassified 62.5 ug Oral
Subject Levothyroxine Other / unclassified 75 ug Oral
Subject Levothyroxine Other / unclassified 88 ug Oral
Subject Levothyroxine Other / unclassified 100 ug Oral

Indications

congenital hypothyroidism