A Study to Assess Growth in Children With Idiopathic Short Stature
Trial Parameters
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Brief Summary
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
Eligibility Criteria
Inclusion Criteria: 1. Participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent. 2. A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https://www.cdc.gov/growthcharts/zscore.htm). 3. Participants who have either never received hGH, or who are currently receiving hGH treatment. 4. Historic stimulation test result with serum or plasma GH level greater than 10 μg/L. 5. Parent(s) or guardian(s) are willing and able to provide written, signed informed consent. Exclusion Criteria: 1. Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, a