Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT06864351
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT06864351
Study Brief:
Protocol Section:
NCT06864351