Actively Recruiting
Prospective Evaluation of OptiThyDose
Led by University Children's Hospital Basel · Updated on 2025-09-03
150
Participants Needed
2
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Prospective Evaluation of OptiThyDose
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborns with confirmed congenital hypothyroidism based on neonatal screening and venous blood tests
- Children up to 18 years old with a new diagnosis, recurrence, or insufficiently controlled Graves' disease under CMZ/MMZ treatment
- Presence of pathological lab values such as suppressed TSH, increased thyroid hormones, or positive Anti-TSH-receptor antibodies in Graves' disease
- Presence of typical clinical signs of Graves' disease if applicable (goitre, tachycardia, palpitations, weight loss, hyperphagia, altered mood)
- Ability to attend scheduled visits and follow treatment and follow-up plans
- Signed informed consent form by patient and/or legal representative according to national laws
You will not qualify if you...
- Newborns of mothers with Graves' disease
- Patients experiencing a life-threatening event
- Children with hyperthyroidism causes other than Graves' disease without elevated Anti-TSH-receptor antibodies, including toxic thyroid nodules, amiodarone-induced hyperthyroidism, McCune Albright syndrome-associated hyperthyroidism, or genetically proven hyperthyroidism from TSH receptor gene mutations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris
Paris, France, 75015
Not Yet Recruiting
2
Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB)
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
Research Team
G
Gabor Szinnai, Prof. MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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