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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-21

Study Completion Date

2025-03-27

Brief Summary

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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).

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Detailed Description

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Newly diagnosed neonates will be randomly assigned to start therapy with LT4 at the initial dose recommended by the Standard of Care (SOC). Infants already on LT4 therapy will continue at the same daily dose within the randomly assigned treatment group (dose adjustments are allowed, if needed based on laboratory parameters and clinical response). Once enrolled, subjects will be treated and followed for 12 months (±1.5 months), participating in 7-8 study visits, consisting of 6-7 inclinic and 1-2 (or more if follow-up visits are required) telemedicine (TM) visits. The total number of visits depends on the age at inclusion.

Conditions

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Congenital Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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 Type EXPERIMENTAL

Tirosint®-SOL

Intervention Type DRUG

Dosage will be according to the USPI and Standard of Care.

Control

Crushed levothyroxine sodium tablets

Group Type ACTIVE_COMPARATOR

Levothyroxine Sodium

Intervention Type DRUG

Tablets will be crushed and dissolved in solution. Dosage will be according to the USPI and Standard of Care.

Interventions

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Tirosint®-SOL

Dosage will be according to the USPI and Standard of Care.

Intervention Type DRUG

Levothyroxine Sodium

Tablets will be crushed and dissolved in solution. Dosage will be according to the USPI and Standard of Care.

Intervention Type DRUG

Other Intervention Names

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levothyroxine sodium oral solution (liquid) levothyroxine sodium tablets

Eligibility Criteria

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Inclusion Criteria

* Male and female patient aged 0 to 9 months
* Primary CH diagnosis with elevated TSH and low or normal FT4, 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 3 weeks;
* Provide and comply with the informed consent.

Exclusion Criteria

* Preterm neonates with a gestational age \< 37 weeks;
* Low birth weight (LBW) or very low birth weight (VLBW) neonates (weight \< 2.5 kg) or VLBW infants (weight \< 1.5 kg);
* Neonates in neonatal intensive care units or requiring admission to NICU or neonates/infants hospitalized or requiring hospitalization or in fragile health conditions (e.g. with serious health problems or complications);
* Neonates with CH diagnosis \> 4 weeks after delivery;
* Diagnosis of primary gastrointestinal disease:

* Gastroesophageal reflux requiring medical therapy (beyond thickening of formula or position);
* Anatomic defects (e.g. intestinal atresia, malrotation, tracheoesophageal fistula, pyloric stenosis, Hirschsprung's disease, gastroschisis);
* Dietary allergy (e.g. cow's milk protein allergy);
* Malabsorption related to cystic fibrosis, celiac disease and others;
* Necrotizing enterocolitis requiring surgical resection;
* Known or suspected adrenal insufficiency (e.g. congenital adrenal hyperplasia, hypopituitarism);
* Diagnosis of congenital cardiac disease, cardiac insufficiency or risk for cardiac failure;
* Diagnosis of chromosomopathy;
* Diagnosis of central hypothyroidism;
* Hypersensitivity to glycerol;
* Concomitant anticonvulsant medications, liothyronine, combination of LT4 and liothyronine, thyroid extracts and/or chronic or long-term use of systemic glucocorticoids
* History of nonadherence with medication or medical visit schedule; or
* Any condition for which, participation would not be in the best interest of the patient or that could limit protocol specified assessments.

Minimum Eligible Age

1 Day

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No