A Study to Assess Growth in Children With Idiopathic Short Stature
Purpose
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
Condition
- Idiopathic Short Stature
Eligibility
- Eligible Ages
- Between 2 Years and 16 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. 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
- 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. .
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Recruiting Locations
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)
Los Angeles, California 90502
Los Angeles, California 90502
Center Of Excellence in Diabetes and Endocrinology
Sacramento, California 95821
Sacramento, California 95821
University of California San Francisco (UCSF)
San Francisco, California 94143
San Francisco, California 94143
Children's National Health System
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Nemours Children's Clinic
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Nicklaus Children's Hospital
Miami, Florida 33155
Miami, Florida 33155
Nemours Children's Health System - Corporate Headquarters
Pensacola, Florida 32514
Pensacola, Florida 32514
Centricity Research
Columbus, Georgia 31904
Columbus, Georgia 31904
St. Luke's Children's Endocrinology
Boise, Idaho 83712
Boise, Idaho 83712
Rocky Mountain Clinical Research - Idaho Falls
Idaho Falls, Idaho 83404
Idaho Falls, Idaho 83404
University of Louisville School Of Medicine - Norton Children's Hospital
Louisville, Kentucky 40202
Louisville, Kentucky 40202
University of Minnesota Medical School - Masonic Children's Hospital - Pediatric Specialty Care Explorer Clinic
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
Bronx, New York 10467
Bronx, New York 10467
UBMD Pediatrics
Buffalo, New York 14203
Buffalo, New York 14203
ACGC Research, NYU Ambulatory Care Garden City
Garden City, New York 11530
Garden City, New York 11530
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - Pediatric Associates
New York, New York 10029
New York, New York 10029
Cincinnati Children's Hospital Medical Center Burnet Campus
Cincinatti, Ohio 45229
Cincinatti, Ohio 45229
Cook Children's Endocrinology
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Charleston Area Medical Center (CAMC) Health System
Charleston, West Virginia 25304
Charleston, West Virginia 25304
More Details
- NCT ID
- NCT06309979
- Status
- Recruiting
- Sponsor
- BioMarin Pharmaceutical