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 Sex
- 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
Phoenix Children's Hospital - Thomas Campus (Main)
Phoenix 5308655, Arizona 5551752 85016
Phoenix 5308655, Arizona 5551752 85016
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921 90027
Los Angeles 5368361, California 5332921 90027
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)
Los Angeles 5368361, California 5332921 90502
Los Angeles 5368361, California 5332921 90502
Children's Hospital of Orange County Main Campus - Orange
Orange 5379513, California 5332921 92868
Orange 5379513, California 5332921 92868
Center Of Excellence in Diabetes and Endocrinology
Sacramento 5389489, California 5332921 95821
Sacramento 5389489, California 5332921 95821
Rady Children's Hospital - San Diego
San Diego 5391811, California 5332921 92123
San Diego 5391811, California 5332921 92123
University of California San Francisco (UCSF)
San Francisco 5391959, California 5332921 94143
San Francisco 5391959, California 5332921 94143
Connecticut Children's Medical Center
Hartford 4835797, Connecticut 4831725 06106-3322
Hartford 4835797, Connecticut 4831725 06106-3322
Yale School of Medicine
New Haven 4839366, Connecticut 4831725 06511
New Haven 4839366, Connecticut 4831725 06511
Children's National Health System
Washington D.C. 4140963, District of Columbia 4138106 20010
Washington D.C. 4140963, District of Columbia 4138106 20010
Nemours Children's Clinic
Jacksonville 4160021, Florida 4155751 32207
Jacksonville 4160021, Florida 4155751 32207
Nicklaus Children's Hospital
Miami 4164138, Florida 4155751 33155
Miami 4164138, Florida 4155751 33155
Nemours Children's Health System - Corporate Headquarters
Pensacola 4168228, Florida 4155751 32514
Pensacola 4168228, Florida 4155751 32514
Centricity Research
Columbus 4188985, Georgia 4197000 31904
Columbus 4188985, Georgia 4197000 31904
St. Luke's Children's Endocrinology
Boise 5586437, Idaho 5596512 83712
Boise 5586437, Idaho 5596512 83712
Rocky Mountain Diabetes Center - Idaho Falls
Idaho Falls 5596475, Idaho 5596512 83404-7596
Idaho Falls 5596475, Idaho 5596512 83404-7596
Rocky Mountain Clinical Research - Idaho Falls
Idaho Falls 5596475, Idaho 5596512 83404
Idaho Falls 5596475, Idaho 5596512 83404
University of Louisville School Of Medicine - Norton Children's Hospital
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40202
Ochsner Health Center for Children - New Orleans
New Orleans 4335045, Louisiana 4331987 70121
New Orleans 4335045, Louisiana 4331987 70121
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109-4000
Ann Arbor 4984247, Michigan 5001836 48109-4000
University of Minnesota Medical School - Masonic Children's Hospital - Pediatric Specialty Care Explorer Clinic
Minneapolis 5037649, Minnesota 5037779 55454
Minneapolis 5037649, Minnesota 5037779 55454
Dartmouth-Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
Lebanon 5088597, New Hampshire 5090174 03756
University of Iowa Stead Family Children's Hospital
Princeton 5102922, New Jersey 5101760 08540
Princeton 5102922, New Jersey 5101760 08540
UBMD Pediatrics
Buffalo 5110629, New York 5128638 14203
Buffalo 5110629, New York 5128638 14203
ACGC Research, NYU Ambulatory Care Garden City
Garden City 5118226, New York 5128638 11530
Garden City 5118226, New York 5128638 11530
New York University Grossman School of Medicine
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - Pediatric Associates
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx 5110266, New York 5128638 10467
The Bronx 5110266, New York 5128638 10467
WakeMed Children's - Pediatric Endocrinology - North Raleigh
Raleigh 4487042, North Carolina 4482348 27615
Raleigh 4487042, North Carolina 4482348 27615
Cincinnati Children's Hospital Medical Center Burnet Campus
Cincinnati 4508722, Ohio 5165418 45229
Cincinnati 4508722, Ohio 5165418 45229
Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418 43205
Columbus 4509177, Ohio 5165418 43205
Prisma Health Children's Hospital - Midlands
Columbia 4575352, South Carolina 4597040 29203
Columbia 4575352, South Carolina 4597040 29203
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232-2578
Nashville 4644585, Tennessee 4662168 37232-2578
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
Dallas 4684888, Texas 4736286 75390
Cook Children's Endocrinology
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
Seattle 5809844, Washington 5815135 98105
Charleston Area Medical Center (CAMC) Health System
Charleston 4801859, West Virginia 4826850 25304
Charleston 4801859, West Virginia 4826850 25304
Charleston Area Medical Center (CAMC) Health System
Charleston 4801859, West Virginia 4826850 25304
Charleston 4801859, West Virginia 4826850 25304
Medical College of Wisconsin, Children's Hospital
Milwaukee 5263045, Wisconsin 5279468 53226
Milwaukee 5263045, Wisconsin 5279468 53226
More Details
- NCT ID
- NCT06309979
- Status
- Recruiting
- Sponsor
- BioMarin Pharmaceutical