A Study to Assess Growth in Children With Idiopathic Short Stature
NCT ID: NCT06309979
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-08-08
2040-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
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
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. .
2 Years
16 Years
ALL
No
Sponsors
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BioMarin Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Phoenix Children's Hospital - Thomas Campus (Main)
Phoenix, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)
Los Angeles, California, United States
Children's Hospital of Orange County Main Campus - Orange
Orange, California, United States
Center Of Excellence in Diabetes and Endocrinology
Sacramento, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale School of Medicine
New Haven, Connecticut, United States
Children's National Health System
Washington D.C., District of Columbia, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nemours Children's Health System - Corporate Headquarters
Pensacola, Florida, United States
Centricity Research
Columbus, Georgia, United States
St. Luke's Children's Endocrinology
Boise, Idaho, United States
Rocky Mountain Diabetes Center - Idaho Falls
Idaho Falls, Idaho, United States
Rocky Mountain Clinical Research - Idaho Falls
Idaho Falls, Idaho, United States
University of Louisville School Of Medicine - Norton Children's Hospital
Louisville, Kentucky, United States
Ochsner Health Center for Children - New Orleans
New Orleans, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota Medical School - Masonic Children's Hospital - Pediatric Specialty Care Explorer Clinic
Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of Iowa Stead Family Children's Hospital
Princeton, New Jersey, United States
UBMD Pediatrics
Buffalo, New York, United States
ACGC Research, NYU Ambulatory Care Garden City
Garden City, New York, United States
New York University Grossman School of Medicine
New York, New York, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - Pediatric Associates
New York, New York, United States
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States
WakeMed Children's - Pediatric Endocrinology - North Raleigh
Raleigh, North Carolina, United States
Cincinnati Children's Hospital Medical Center Burnet Campus
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Prisma Health Children's Hospital - Midlands
Columbia, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Cook Children's Endocrinology
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Charleston Area Medical Center (CAMC) Health System
Charleston, West Virginia, United States
Charleston Area Medical Center (CAMC) Health System
Charleston, West Virginia, United States
Medical College of Wisconsin, Children's Hospital
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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111-903
Identifier Type: -
Identifier Source: org_study_id
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