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Thyroid Hormone Replacement

Tirosint-SOL for Congenital Hypothyroidism

Phase 4
Waitlist Available
Research Sponsored by IBSA Institut Biochimique SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary CH diagnosis with elevated TSH and low T4, requiring treatment with LT4, under either of the following conditions: Neonates newly diagnosed with primary CH and needing to initiate LT4 therapy, or Infants previously diagnosed with primary CH and who are already on LT4 therapy for at least 4 weeks
Male and female patient aged 0 to 9 months
Must not have
Neonates in neonatal intensive care units or requiring admission to NICU or neonates/infants hospitalized or requiring hospitalization
Low birth weight and very low birth weight neonates (weight < 2.5 kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 22 months based on age group
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects from both treatments are similar since they contain the same active ingredient and may include symptoms like rapid heartbeat, sweating, restlessness or sleep disturbances due to excessive thyroid hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have primary congenital hypothyroidism and need or am on LT4 therapy.
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I am a baby aged 9 months or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My newborn needs or is in intensive care.
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My newborn weighs less than 2.5 kg.
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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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My baby was born before 37 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 22 months based on age group
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 22 months based on age group for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
LT4 dose required to maintain TSH in target range (unit: mcg/kg/day)
Secondary study objectives
Frequency of dose adjustments
Growth pattern for body weight
Growth pattern for head circumference
+9 more
Other study objectives
Time to normalize FT4 in neonates
Time to normalize TSH in neonates

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The primary treatment for Congenital Hypothyroidism is synthetic thyroxine (T4) replacement, such as Tirosint®-SOL. This treatment works by providing the body with the hormone thyroxine, which is deficient in patients with Congenital Hypothyroidism. Thyroxine is crucial for normal growth, brain development, and metabolism. By supplementing this hormone, the treatment helps normalize thyroid function, ensuring proper physical and cognitive development in affected infants. Accurate and consistent dosing, as seen with liquid formulations like Tirosint®-SOL, is particularly important to maintain stable thyroid hormone levels and optimize developmental outcomes.
Delayed Diagnosis of Congenital Hypothyroidism in a Child with Trisomy 21 and Biotinidase Deficiency and Successful Use of Levothyroxine Sodium Oral Solution.

Find a Location

Who is running the clinical trial?

IBSA Institut Biochimique SALead Sponsor
40 Previous Clinical Trials
10,124 Total Patients Enrolled
CromsourceIndustry Sponsor
17 Previous Clinical Trials
3,089 Total Patients Enrolled
Giuseppe MautoneStudy DirectorIBSA Head of R&D Scientific Affairs
1 Previous Clinical Trials
488 Total Patients Enrolled

Media Library

Tirosint®-SOL (Thyroid Hormone Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05228184 — Phase 4
Tirosint®-SOL (Thyroid Hormone Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05228184 — Phase 4
Congenital Hypothyroidism Research Study Groups: Treatment, Control
Congenital Hypothyroidism Clinical Trial 2023: Tirosint®-SOL Highlights & Side Effects. Trial Name: NCT05228184 — Phase 4
~13 spots leftby Apr 2025