NCT06382155
Idiopathic Short Stature
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.
The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH), in children with idiopathic short stature (ISS).
All
3 Years to 10 Years
No
Vosoritide Injection, Human Growth Hormone, Placebo
Phase 2
Interventional
100
2024-10-21
2025-01-20
Sacramento, California, United States
Torrance, California, United States
Pensacola, Florida, United States
Columbus, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Bronx, New York, United States
Buffalo, New York, United States
Key Inclusion Criteria:
1. 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 charts
2. Tanner Stage 1, at time of signing the ICF (unless too young to stage).
Key Exclusions:
1. Known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, Turner syndrome, disproportionate skeletal dysplasias, abnormal SHOX gene analysis, or Rasopathy (including Noonan syndrome)
2. Previous treatment with a growth promoting agent
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