Overview
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
Eligibility
Inclusion Criteria:
- Participants must be > 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent.
- Participants whose height Z-score is ≤ -2.5 SDs compared to age and sex matched population norms.
- Participants are ambulatory and able to stand without assistance (not applicable for children who are < 5 years of age and less than 104 cm in length).
- Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.
- Participants are willing and able to perform all study procedures.
Exclusion Criteria:
- 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, at the discretion of the Medical Monitor.
- Known presence of pituitary hormone deficiencies.
- Bone age advanced over chronological age by more than 3 years.
- Active malignancy, active chemotherapy or radiation therapy for neoplasia.
- Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit.
- Ongoing treatment for concurrent disease or condition that, in the view of the investigator, would interfere with study participation, for any reason. Participants receiving treatments for attention deficit hyperactivity disorder are not excluded.