Actively Recruiting

Age: 2Years - 16Years
All Genders
NCT06309979

A Study to Assess Growth in Children With Idiopathic Short Stature

Led by BioMarin Pharmaceutical · Updated on 2025-11-14

300

Participants Needed

40

Research Sites

855 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Study to Assess Growth in Children With Idiopathic Short Stature

Who Can Participate

Age: 2Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be older than 2 years and 14 years or younger for females, or 16 years or younger for males at consent signing
  • Height Z-score must be -2.25 standard deviations or lower compared to peers of the same age and sex using CDC growth charts
  • Participants may have never received human growth hormone (hGH) or may currently be receiving hGH treatment
  • Historic growth hormone stimulation test showing serum or plasma GH level greater than 10 bcg/L
  • Parent or guardian must be willing and able to provide signed informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of systemic diseases that may cause short stature, such as renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic, or metabolic diseases, unless well controlled as approved by the Medical Monitor
  • Known pituitary hormone deficiencies
  • Bone age advanced more than 3 years beyond chronological age
  • For hGH-nafve participants, historic stimulation test GH level over 10 bcg/L or serum IGF-1 in normal age range (-1.00 to +2.00 SDs)
  • For participants on hGH treatment, historic pre-treatment stimulation test GH level over 10 bcg/L or serum IGF-1 between -1.00 and +2.00 SDs
  • Received any investigational product or medical device within 6 months before screening visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 40 locations

1

Phoenix Children's Hospital - Thomas Campus (Main)

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

3

Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)

Los Angeles, California, United States, 90502

Actively Recruiting

4

Children's Hospital of Orange County Main Campus - Orange

Orange, California, United States, 92868

Actively Recruiting

5

Center Of Excellence in Diabetes and Endocrinology

Sacramento, California, United States, 95821

Actively Recruiting

6

Rady Children's Hospital - San Diego

San Diego, California, United States, 92123

Actively Recruiting

7

University of California San Francisco (UCSF)

San Francisco, California, United States, 94143

Actively Recruiting

8

Connecticut Children's Medical Center

Hartford, Connecticut, United States, 06106-3322

Actively Recruiting

9

Yale School of Medicine

New Haven, Connecticut, United States, 06511

Actively Recruiting

10

Children's National Health System

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

11

Nemours Children's Clinic

Jacksonville, Florida, United States, 32207

Actively Recruiting

12

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

Actively Recruiting

13

Nemours Children's Health System - Corporate Headquarters

Pensacola, Florida, United States, 32514

Actively Recruiting

14

Centricity Research

Columbus, Georgia, United States, 31904

Actively Recruiting

15

St. Luke's Children's Endocrinology

Boise, Idaho, United States, 83712

Actively Recruiting

16

Rocky Mountain Diabetes Center - Idaho Falls

Idaho Falls, Idaho, United States, 83404-7596

Actively Recruiting

17

Rocky Mountain Clinical Research - Idaho Falls

Idaho Falls, Idaho, United States, 83404

Actively Recruiting

18

University of Louisville School Of Medicine - Norton Children's Hospital

Louisville, Kentucky, United States, 40202

Actively Recruiting

19

Ochsner Health Center for Children - New Orleans

New Orleans, Louisiana, United States, 70121

Actively Recruiting

20

University of Michigan

Ann Arbor, Michigan, United States, 48109-4000

Actively Recruiting

21

University of Minnesota Medical School - Masonic Children's Hospital - Pediatric Specialty Care Explorer Clinic

Minneapolis, Minnesota, United States, 55454

Actively Recruiting

22

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

23

University of Iowa Stead Family Children's Hospital

Princeton, New Jersey, United States, 08540

Actively Recruiting

24

UBMD Pediatrics

Buffalo, New York, United States, 14203

Actively Recruiting

25

ACGC Research, NYU Ambulatory Care Garden City

Garden City, New York, United States, 11530

Actively Recruiting

26

New York University Grossman School of Medicine

New York, New York, United States, 10016

Actively Recruiting

27

Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - Pediatric Associates

New York, New York, United States, 10029

Actively Recruiting

28

Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)

The Bronx, New York, United States, 10467

Actively Recruiting

29

WakeMed Children's - Pediatric Endocrinology - North Raleigh

Raleigh, North Carolina, United States, 27615

Actively Recruiting

30

Cincinnati Children's Hospital Medical Center Burnet Campus

Cincinnati, Ohio, United States, 45229

Actively Recruiting

31

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

32

Prisma Health Children's Hospital - Midlands

Columbia, South Carolina, United States, 29203

Actively Recruiting

33

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232-2578

Actively Recruiting

34

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

35

Cook Children's Endocrinology

Fort Worth, Texas, United States, 76104

Actively Recruiting

36

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

37

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

38

Charleston Area Medical Center (CAMC) Health System

Charleston, West Virginia, United States, 25304

Actively Recruiting

39

Charleston Area Medical Center (CAMC) Health System

Charleston, West Virginia, United States, 25304

Actively Recruiting

40

Medical College of Wisconsin, Children's Hospital

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

T

Trial Specialist

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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