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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
300 participants
OBSERVATIONAL
2024-08-08
2040-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
BioMarin Pharmaceutical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Pamela Smith
Role: primary
Anna Ryabets-Lienhard
Role: primary
Dr Lynda Elizabeth Polgreen
Role: primary
Amrit Bhangoo
Role: primary
Dr Gnanagurudasan Prakasam
Role: primary
Mary (Marybeth) Patterson
Role: primary
Dr Hannah Chesser
Role: primary
Nordie Bilbao
Role: primary
Anisha Patel
Role: primary
Dr Andrew Dauber
Role: primary
Dr Larry Fox
Role: primary
Dr Adriana Carrillo
Role: primary
Dr Jean-Claude Desmangles
Role: primary
Dr Steven Bruce Leichter
Role: primary
Dr Daniel Flynn
Role: primary
Joshua M. Smith
Role: primary
Dr Joshua Smith
Role: primary
Dr Catalina Cabrera
Role: primary
Carmen Mironovici
Role: primary
Inas H Thomas
Role: primary
Dr Nishitha Pillai
Role: primary
Robert Gensure
Role: primary
Michael Tansey
Role: primary
Dr Teresa Quattrin
Role: primary
Dr Paul Saengar
Role: primary
Emily Breidbart
Role: primary
Dr Robert Rapaport
Role: primary
Dr Laurie Cohen
Role: primary
William Lagarde
Role: primary
Dr Gajanthan Muthuvel
Role: primary
Sasigarn Bowden
Role: primary
Alison Lunsford
Role: primary
Scott Ward
Role: primary
Nadia Merchant
Role: primary
Dr Joel Steelman
Role: primary
Jennifer Bell
Role: primary
Patricia Fechner
Role: primary
Dr Sachin Bendre
Role: primary
Sachin Bendre
Role: primary
Donald Basel
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
111-903
Identifier Type: -
Identifier Source: org_study_id