A Study to Assess Growth in Children With Idiopathic Short Stature (NCT06309979) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Assess Growth in Children With Idiopathic Short Stature
United States300 participantsStarted 2024-08-08
Plain-language summary
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
Who can participate
Age range
2 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. A 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 chart (https://www.cdc.gov/growthcharts/zscore.htm).
. Participants who have either never received hGH, or who are currently receiving hGH treatment.
. Historic stimulation test result with serum or plasma GH level greater than 10 μg/L.
. Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.
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 one or more pituitary hormone deficiencies
. Bone age advanced over chronological age by more than 3 years.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in annualized growth velocity (AGV)
Timeframe: Every 6 months through end of study, up to 15 years
2
Change in Height Z-score
Timeframe: Every 6 months through end of study, up to 15 years
3
Change in Standing Height
Timeframe: Every 6 months through end of study, up to 15 years
4
Change in BMI
Timeframe: Every 6 months through end of study, up to 15 years
5
Change in BMI Z-score
Timeframe: Every 6 months through end of study, up to 15 years
. For hGH naïve participants, historic stimulation test result with serum or plasma GH level greater than 10 μg/L or serum IGF-1 in the normal range for age (between -1.00 SDs and +2.00 SDs).
. For participants currently on hGH treatment, historic results before GH treatment of stimulation test with serum or plasma GH level greater than 10 μg/L or serum IGF-1 test between -1.00 SDs and +2.00 SDs.
. Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .