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New treatment option for Thyroid Diseases
Official title Prospective Evaluation of OptiThyDose
ClinicalTrials.gov ID: NCT06864351
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- Congenital hypothyroidism (CH)
- Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample Graves'...
- 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
You likely can't join 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Basel, Canton of Basel-City, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Basel, Canton of Basel-City, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.