Prospective Evaluation of OptiThyDose
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).
| Condition(s) | Thyroid Diseases, Congenital Hypothyroidism, Graves Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 pa |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Children's Hospital Basel |
| Locations | Paris, France; Basel, Canton of Basel-City, Switzerland |
| Start date | 2025-08-28 |
| NCT ID | NCT06864351 |
| Official listing | https://clinicaltrials.gov/study/NCT06864351 |