NCT06309979 A Study to Assess Growth in Children With Idiopathic Short Stature
| NCT ID | NCT06309979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BioMarin Pharmaceutical |
| Condition | Idiopathic Short Stature |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-08-08 |
| Primary Completion | 2040-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-08-08 with a primary completion date of 2040-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
Eligibility Criteria
Inclusion Criteria: 1. Participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent. 2. 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). 3. Participants who have either never received hGH, or who are currently receiving hGH treatment. 4. Historic stimulation test result with serum or plasma GH level greater than 10 μg/L. 5. Parent(s) or guardian(s) are willing and able to provide written, signed informed consent. Exclusion Criteria: 1. 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. 2. Known presence of one or more pituitary hormone deficiencies 3. Bone age advanced over chronological age by more than 3 years. 4. 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). 5. 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. 6. Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06309979 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 16 Years, studying Idiopathic Short Stature. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06309979 currently recruiting?
Yes, NCT06309979 is actively recruiting participants. Contact the research team at Medinfo@bmrn.com for enrollment information.
Where is the NCT06309979 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Los Angeles, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT06309979 clinical trial?
NCT06309979 is sponsored by BioMarin Pharmaceutical. The trial plans to enroll 300 participants.