Tirosint-SOL for Congenital Hypothyroidism

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: IBSA Institut Biochimique SA

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing whether a liquid thyroid hormone medication (Tirosint®-SOL) is better than crushed tablets for infants with congenital hypothyroidism. The treatment provides the necessary thyroid hormone that these infants need for proper growth and development. Tirosint®-SOL is a liquid formulation of thyroid hormone, which has been shown to provide better thyroid hormone control and improved quality of life compared to tablet forms.

Research Team

Giuseppe Mautone

Principal Investigator

IBSA Head of R&D Scientific Affairs

Eligibility Criteria

This trial is for babies aged 0 to 9 months with Congenital Hypothyroidism. It's open to those newly diagnosed or already on treatment for at least 4 weeks, but not for preterm infants, those in intensive care, with primary gastrointestinal diseases, severe heart conditions, chromosomal disorders, certain medication use or allergies.

Inclusion Criteria

I have primary congenital hypothyroidism and need or am on LT4 therapy.

Provide and comply with the informed consent

I am a baby aged 9 months or younger.

Exclusion Criteria

My newborn needs or is in intensive care.

My newborn weighs less than 2.5 kg.

If you have certain digestive, heart, or hormone-related conditions, or if taking certain medications, participating in this study might not be safe for you.

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Treatment Details

Interventions

Levothyroxine Sodium (Thyroid Hormone Replacement)
Tirosint®-SOL (Thyroid Hormone Replacement)

Trial OverviewThe study compares two forms of thyroid hormone replacement: Tirosint®-SOL and the traditional levothyroxine sodium tablets. Babies will be randomly assigned to either the new liquid solution (2 out of every 3) or the standard crushed tablet form.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

Tirosint®-SOL (levothyroxine sodium) oral solution (IBSA Pharma Inc.) at the following strengths: 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100 mcg.

Group II: ControlActive Control1 Intervention

Crushed levothyroxine sodium tablets