Tirosint-SOL for Congenital Hypothyroidism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new liquid form of the thyroid hormone treatment, Tirosint-SOL, for babies with congenital hypothyroidism (CH), a condition where the thyroid gland doesn't produce enough hormones. The study compares Tirosint-SOL to the usual crushed tablet form of the same hormone. It includes babies diagnosed with CH who are either just starting treatment or have been on similar therapy for at least three weeks. This trial may suit infants diagnosed with CH who are currently on or need thyroid hormone treatment. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anticonvulsant medications, liothyronine, a combination of LT4 and liothyronine, thyroid extracts, or long-term systemic glucocorticoids.
What is the safety track record for these treatments?
Research has shown that Tirosint-SOL, a liquid form of levothyroxine sodium, is safe in various situations, including during pregnancy. No reports of increased major birth defects have emerged, indicating it is well-tolerated by vulnerable groups. Additionally, studies on children taking Tirosint-SOL demonstrate it is generally well-tolerated. This safety information reassures those considering joining a trial with Tirosint-SOL, suggesting the treatment is safe for people.12345
Why are researchers enthusiastic about this study treatment?
Unlike traditional levothyroxine sodium tablets for congenital hypothyroidism, Tirosint-SOL is an oral solution, which can be a game-changer, especially for infants and young children who may have difficulty swallowing pills. This liquid formulation ensures more precise dosing and potentially better absorption, which can lead to more stable thyroid hormone levels. Researchers are excited about Tirosint-SOL because it offers flexibility in dosing and administration, catering to individual patient needs more effectively than crushed tablets.
What evidence suggests that Tirosint-SOL might be an effective treatment for congenital hypothyroidism?
Research has shown that Tirosint-SOL, a liquid form of levothyroxine, effectively treats congenital hypothyroidism (CH) in infants. This trial will compare Tirosint-SOL with crushed levothyroxine sodium tablets. Tirosint-SOL improves thyroid function, crucial for normal growth and development. It has been proven safe and effective, providing a reliable treatment for infants with CH. Liquid forms like Tirosint-SOL are often easier for infants to take than crushed tablets. Experts agree that levothyroxine solutions benefit CH treatment by supporting healthy development in children.56789
Who Is on the Research Team?
Giuseppe Mautone
Principal Investigator
IBSA Head of R&D Scientific Affairs
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Tirosint®-SOL or crushed levothyroxine sodium tablets based on randomization
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Levothyroxine Sodium
- Tirosint®-SOL
Find a Clinic Near You
Who Is Running the Clinical Trial?
IBSA Institut Biochimique SA
Lead Sponsor
Cromsource
Industry Sponsor