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Thyroid Hormone Replacement

Tirosint-SOL for Congenital Hypothyroidism

Phase 4

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 22 months based on age group

Awards & highlights

Study Summary

This trial is testing a new medication, Tirosint-SOL, to see if it is better than the current treatment for Congenital Hypothyroidism.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 22 months based on age group

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hormonal (TFTs) profile for FT4

Hormonal (TFTs) profile for TSH

Hormonal (TFTs) profile for TT4

+3 more

Secondary outcome measures

Frequency of dose adjustments

Growth patterns for body weight

Growth patterns for head circumference

+1 more

Other outcome measures

Adverse events

Signs and symptoms of hyperthyroidism

Signs and symptoms of hypothyroidism

+2 more

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: 25, 37.5, 44, 50, 62.5, 75, 88, 100 mcg.

Group II: ControlActive Control1 Intervention

Crushed levothyroxine sodium tablets

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

IBSA Institut Biochimique SALead Sponsor

36 Previous Clinical Trials

9,831 Total Patients Enrolled

CromsourceIndustry Sponsor

17 Previous Clinical Trials

3,091 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity of this experiment?

"In order for this medical trial to be conducted successfully, 126 eligible patients need to be recruited. The study's sponsor - IBSA Institut Biochimique SA - will coordinate the investigation from sites including Children's Hospital of Los Angeles in California and University of California San Francisco in Ohio."

Answered by AI

In what ways is this research project expected to produce positive outcomes?

"This trial, which has a span of up to 22 months based on the age group involved, is primarily assessing patient hormonal profiles in relation to thyroxine levels. Secondary goals include measuring body length (cm), weight (kg) and head circumference (cm)."

Answered by AI

Has Tirosint®-SOL been sanctioned by the Food and Drug Administration?

"There is an abundance of evidence suggesting Tirosint®-SOL's safety, thus leading to a score of 3."

Answered by AI

Is registration currently open for this experiment?

"Affirmative. As indicated on clinicaltrials.gov, the medical trial which was posted in December 2021 is actively recruiting patients. 126 volunteers are required from 11 different sites for this study's completion."

Answered by AI

Is the eligibility age for this trial over 30 years of age?

"This trial specifies that eligible participants should be between 1 day and 9 months of age. There are 11 different studies for those aged 65 or over, while 3 trials cater to applicants below 18 years old."

Answered by AI

What demographic is eligible for participation in this clinical experiment?

"This research project is recruiting 126 individuals, between 24 hours old and 9 months of age, who are currently experiencing endemic cretinism. To be included in this trial the participants must meet these criteria: male or female infants aged 0 to 9 months with newly identified primary CH requiring LT4 therapy or those previously diagnosed with primary CH on LT4 treatment for at least a month that have given their informed consent."

Answered by AI

What is the current count of hospitals conducting this trial?

"At this time, 11 various medical centres are enrolling patients for the study. Locations in Los Angeles, San Francisco and Cincinnati can be found alongside 8 other clinics across the nation. To reduce travel costs when participating, it is crucial to select a clinic close-by."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05228184.

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