Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT00572156
Eligibility Criteria:
Inclusion Criteria:
* Parents or legally authorized representatives must give signed informed consent before any trial-related activities
* IGF-1 SDS of ≤ -1 for age and gender
* Short stature, as defined by a height SDS of ≤ -2 for age and gender
* Chronological age ≥ 5 years
* Bone age ≤ 11 years in boys and ≤ 9 years in girls
* GH sufficiency, defined as a maximal stimulated GH response of greater than or equal to 10 ng/mL at Visit 2 (note: upon approval of the Medical Monitor, the result of a prior GH stimulation test may satisfy this requirement).
* Prepubertal status
* Adequate nutrition as evidenced by a body mass index (BMI) greater than or equal to the 5th percentile for age and gender
Exclusion Criteria:
* Severe Primary IGFD (defined as height and IGF-1 SDS ≤ 3, and stimulated GH response greater than or equal to 10 ng/mL)
* Prior or current use of medications with the potential to alter growth patterns including GH, IGF-1, IGFBP-3, gonadotrophin agonists (e.g., Lupron), aromatase inhibitors, androgens and estrogens
* Known or suspected allergy to rhGH, rhIGF-1 or a constituent of their formulations
* Current use of medications for attention deficit disorder
* A chronic health condition that requires anti-inflammatory steroids or daily medication unless approved by the Medical Monitor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT00572156
Study Brief:
Protocol Section:
NCT00572156