A Study to Assess Growth in Children With Idiopathic Short Stature

Recruiting now

Conditions studied: Idiopathic Short Stature

In brief

Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.

Key facts

Study ID

NCT06309979

Run by

BioMarin Pharmaceutical

People needed

300

Starts

2024-08-08

Expected to finish

2040-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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. .

Where it is running

• University of Iowa Stead Family Children's Hospital — Princeton, New Jersey, United States (enrolling)
• UBMD Pediatrics — Buffalo, New York, United States (enrolling)
• ACGC Research, NYU Ambulatory Care Garden City — Garden City, New York, United States (enrolling)
• Connecticut Children's Medical Center — Hartford, Connecticut, United States (enrolling)
• Center Of Excellence in Diabetes and Endocrinology — Sacramento, California, United States (enrolling)
• Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM) — The Bronx, New York, United States (enrolling)
• Children's National Health System — Washington D.C., District of Columbia, United States (enrolling)
• Cincinnati Children's Hospital Medical Center Burnet Campus — Cincinnati, Ohio, United States (enrolling)
• Nemours Children's Clinic — Jacksonville, Florida, United States (enrolling)
• Prisma Health Children's Hospital - Midlands — Columbia, South Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Nicklaus Children's Hospital — Miami, Florida, United States (enrolling)
• Nemours Children's Health System - Corporate Headquarters — Pensacola, Florida, United States (enrolling)
• Centricity Research — Columbus, Georgia, United States (enrolling)
• St. Luke's Children's Endocrinology — Boise, Idaho, United States (enrolling)
• Rocky Mountain Clinical Research - Idaho Falls — Idaho Falls, Idaho, United States (enrolling)
• University of Louisville School Of Medicine - Norton Children's Hospital — Louisville, Kentucky, United States (enrolling)
• Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed) — Los Angeles, California, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• University of California San Francisco (UCSF) — San Francisco, California, United States (enrolling)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Medical College of Wisconsin, Children's Hospital — Milwaukee, Wisconsin, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County Main Campus - Orange — Orange, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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