| NCT ID | NCT06864351 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Children's Hospital Basel |
| Condition | Thyroid Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-08-28 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Gabor Szinnai, Prof. MD, PhD
PRINCIPAL INVESTIGATOR
Paediatric Endocrinology, UKBB
Frequently Asked Questions
Who can join the NCT06864351 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Thyroid Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864351 currently recruiting?
Yes, NCT06864351 is actively recruiting participants. Contact the research team at Gabor.Szinnai@ukbb.ch for enrollment information.
Where is the NCT06864351 trial being conducted?
This trial is being conducted at Paris, France, Basel, Switzerland.
Who is sponsoring the NCT06864351 clinical trial?
NCT06864351 is sponsored by University Children's Hospital Basel. The principal investigator is Gabor Szinnai, Prof. MD, PhD at Paediatric Endocrinology, UKBB. The trial plans to enroll 150 participants.