Prospective Evaluation of OptiThyDose
Recruiting now · Not applicable
Conditions studied: Thyroid Diseases, Congenital Hypothyroidism, Graves Disease
In brief
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).
Key facts
- Study ID
- NCT06864351
- Run by
- University Children's Hospital Basel
- People needed
- 150
- Starts
- 2025-08-28
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2025-09-03
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB) — Basel, Canton of Basel-City, Switzerland (enrolling)
- Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris — Paris, France
Full record on ClinicalTrials.gov
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