Interventional Study of Vosoritide for the Treatment of Children With Hypochondroplasia

Exclusion Criteria

• •1. Short stature condition other than HCH
• •2. Have an unstable condition likely to require surgical intervention during the study.
• •3. Evidence of decreased growth velocity and/or growth plate closure
• •4. Taking any of the prohibited medications
• •5. Treated with growth hormone, insulin-like growth factor 1 (IGF-1), or anabolic steroids
• •6. Planned or expected to have limb-lengthening surgery during the study period.
• •7. Planned or expected bone-related surgery (ie, surgery involving disruption of bone cortex, excluding tooth extraction), during the study period
• •8. Require any investigational agent prior to completion of study period.
• •9. Received vosoritide or another investigational product or investigational medical device in the past
• •10. Have used any investigational product or investigational medical device for the treatment of HCH or short stature at any time, including vosoritide
• •11. Have current malignancy, history of malignancy, or currently under work-up for suspected malignancy.
• •12. Have known hypersensitivity to vosoritide or its excipients.
• •13. Concurrent disease or condition that, in the view of the investigator, would interfere with study participation or safety evaluations, for any reason.