A Multicenter, Observational Study to Characterize Growth in Children With Idiopathic Short Stature
BioMarin Pharmaceutical
Summary
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
Eligibility
- Age range
- 2–16 years
- Sex
- All
- Healthy volunteers
- No
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…