The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.
Who can participate
Age range2 Years – 16 Years
SexALL
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Inclusion Criteria:
* One of the following diagnoses and candidacy for SAIZEN® therapy:
A) GHD: documented pre-established diagnosis of GHD with a growth hormone (GH) peak response of \<10 microgram per liter (mcg/L) with 2 GH stimulation tests, without priming with oestradiol.
B) Turner syndrome: documented pre-established diagnosis by karyotype.
* Prepubertal status according to Tanner Pre-established history of normal thyroid function or adequate substitution for at least 3 months.
* Weight for stature within the population specific normal range (\>5th and \<95th percentiles) for gender Willingness and ability to comply with the protocol for the duration of the study.
* Parent's or guardian's written informed consent, given before any study related procedure that is not part of the subject's normal medical care, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given.
Exclusion Criteria:
* Acquired GHD due to central nervous system tumour, trauma, infection, infiltration (documented by imaging), and history of irradiation or cranial surgery
* Previous treatment with GH, growth hormone-releasing hormone (GHRH), anabolic steroids or any treatment affecting growth.
* Previous treatment with corticosteroids, except in case of topical or inhaled corticosteroid administration for atopic disease. Corticosteroids for…
What they're measuring
1
Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1