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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT01243892
Eligibility Criteria:
Inclusion Criteria:
* Bone age less than or equal to (\</=) 8 years (females) or \</= 10 years (males) as determined by x-ray of the left hand and wrist obtained within six months before enrollment
* Prepubertal males and females by physical exam
* Naive to rhGH therapy
* Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable etiology for short stature
* Height standard deviation score (Ht SDS) \</= -1.5 (\</= 5th percentile) for IGHD participants; Ht SDS \</= -2.25 (\</= 1.2 percentile) for ISS participants
Exclusion Criteria:
* Short stature etiologies other than IGHD or ISS
* Participants receiving chronic corticosteroid therapy (greater than \[\>\] 3 months) for other medical conditions
* Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
* Females with turner syndrome
* Any previous rhGH treatment
* Participation in another simultaneous medical investigation or trial
* Pediatric participants with closed epiphyses
* Participants prescribed rhGH doses outside the variance of NCGS control participant dosing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
14 Years
Study:
NCT01243892
Study Brief:
Protocol Section:
NCT01243892