Prospective Evaluation of OptiThyDose (NCT06864351) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Evaluation of OptiThyDose
France, Switzerland150 participantsStarted 2025-08-28
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 ca…