Overview

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

Status:
Recruiting
Trial end date:
2023-06-15
Target enrollment:
Participant gender:
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).
Phase:
Phase 4
Details
Lead Sponsor:
IBSA Institut Biochimique SA
Collaborator:
Cromsource