Prospective Evaluation of OptiThyDose
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity Children's Hospital Basel
About this trial
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
Qualifiers
Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample
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)
The study participant must be accessible for scheduled visits, treatment and follow-up.
Disqualifiers
Exclusion of newborns from mothers with GD
Exclusion of patients in case of a life-threatening event
known toxic thyroid nodules proven by ultrasound/scintigraphy
known amiodarone induced hyperthyroidism
Trial design
Treatments tested in this trial
- OptiThyDose
Treatment groups
150 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov