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Clinical Trials in France / NCT06864351
Recruiting Not applicable

Prospective Evaluation of OptiThyDose

NCT06864351 · tracked via the Priya Life Science France tracker
Sponsor
University Children's Hospital Basel
Phase
Not applicable
Started
2025-08-28
Last updated
2026-10-02

Condition(s) studied

Thyroid DiseasesCongenital HypothyroidismGraves Disease

Investigational drug(s) / intervention(s)

OptiThyDose

OptiThyDose: OptiThyDose is an iterative mathematical model applied at each patient visit, consisting of three components: (i) a disease-specific pharmacometrics (PMX) model, (ii) an empirical Bayesian estimation (EBE) component, and (iii) an optimal control theory (OCT) component. It calculates the optimal LT4 or CMZ/MMZ dose to maintain Free Thyroxine (FT4) levels within the upper half of the age-specific reference range, integrating past clinical and lab data. Dosing follows international guidelines, with physicians able to consult OptiThyDose for individualized dosing within recommended ranges. At each outpatient visit, the physician can either (A) prescribe a dose within OptiThyDose's suggested range or (B) choose a dose based on personal experience.

Study summary

The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: Congenital hypothyroidism (CH) * Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample Graves' disease (GD) * Children until 18 years with new diagnosis of GD, recurrence of GD, or insufficiently controlled GD under CMZ/MMZ during follow-up according to: * Pathological lab values (suppressed TSH, increased thyroid hormone levels, positive Anti-TSH-receptor antibodies) * Typical clinical picture, if present (goitre, tachycardia, palpitations, weight loss, hyperphagia, altered mood) CH and GD * The study participant must be accessible for scheduled visits, treatment and follow-up. * Signed Informed Consent form (ICF) obtained prior to any study related procedure. Written IC for study participation must be signed and dated by the patient and/or his/her legal representative(s) in accordance with national legal requirements Exclusion Criteria: CH and GD * Exclusion of newborns from mothers with GD * Exclusion of patients in case of a life-threatening event GD * Exclusion of children with known other aetiologies of hyperthyroidism than GD without elevated Anti-TSH-receptor antibodies e.g.: * known toxic thyroid nodules proven by ultrasound/scintigraphy * known amiodarone induced hyperthyroidism * known McCune Albright syndrome (based on clinical, laboratory, and genetic diagnosis) associated hyperthyroidism * known genetically proven hyperthyroidism caused by activating mutations of the TSH receptor gene

Primary outcome measure(s)

  • Serum Free Thyroxine (FT4) value — 90 days post treatment start
    The serum Free Thyroxine (FT4) values is evaluated. FT4, interpreted according to the age of patients, is used in clinical routine as marker of the adequacy of: * Thyroid hormone substitution with LT4 of insufficient thyroid function in patients with CH (low FT4 levels in case of under-dosing of LT4, high FT4 levels in case of over-dosing of LT4) * Suppression of overactive thyroid function with CMZ/MMZ in patients with GD (low FT4 levels in case of over-dosing of CMZ/MMZ, high FT4 levels in case of under-dosing of CMZ/MMZ)

Trial sites (7)

FacilityCityRegionStatus
Arabkir Medical Cente & Institute of child and adolescent Health LLC Yerevan Armenia Recruiting
Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris Paris France Not Yet Recruiting
Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB) Basel Canton of Basel-City Recruiting
Centre hospitalier universitaire vaudois (CHUV) Lausanne Suisse Recruiting
Kinderspital Zentralschweiz (LUKS) Lucerne Switzerland Recruiting
Ostschweizer Kinderspital (OKS) Sankt Gallen Switzerland Recruiting
Universitäts-Kinderspital Zürich - Eleonorenstiftung Zurich Switzerland Recruiting

Other trials for the same condition

Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis Recruiting
Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy Recruiting
Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06864351 on ClinicalTrials.gov ↗ ← All trials in France