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

NCT05228184 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-10-23

No results posted yet for this study

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).

Conditions

  • Congenital Hypothyroidism

Interventions

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.

Sponsors & Collaborators

  • Cromsource

    collaborator INDUSTRY

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Giuseppe Mautone · IBSA Head of R&D Scientific Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
9 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2025-03-27
Completion
2025-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05228184 on ClinicalTrials.gov