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A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature
Sponsor: BioMarin Pharmaceutical
Summary
The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH)(hGH; only in the United States), in children with idiopathic short stature (ISS).
Official title: A Phase 2, Randomized, Controlled, Multicenter Study of Vosoritide in Children With Idiopathic Short Stature
Key Details
Gender
All
Age Range
3 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-10-21
Completion Date
2036-12
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Vosoritide Injection
Experimental Drug Lyophilized powder for reconstitution
Human Growth Hormone
Commercial product containing somatotropin
Placebo
Lyophilized powder for reconstitution
Locations (47)
Consano Clinical Research, LLC
California City, California, United States
Rady Children's Hospital - San Diego
California City, California, United States
Children's Hospital of Orange County Main Campus - Orange
California City, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Oakland Research Institute
Oakland, California, United States
Center Of Excellence in Diabetes and Endocrinology
Sacramento, California, United States
Lundquist Institute for Biomedical Innovation (LA BioMed)
Torrance, California, United States
The Children's National Research Institute
Washington D.C., District of Columbia, United States
Nemours Children's Specialty Care Jacksonville
Jacksonville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Optimal Research Sites
Orange City, 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 Clinical Research - Idaho Falls
Idaho Falls, Idaho, United States
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, United States
Kentucky Children's Hospital
Lexington, Kentucky, United States
University of Louisville School of Medicine
Louisville, Kentucky, United States
Velocity Clinical Research - MedPharmics - Lafayette
Lafayette, Louisiana, 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 Masonic Children's Hospital
Minneapolis, Minnesota, United States
UBMD Pediatrics
Buffalo, New York, United States
NYU Langone Ambulatory Care Garden City
Garden City, New York, United States
Atlantic Health Children's Specialty Center at Morristown
New York, New York, United States
The Clinical and Translational Science Institute
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
University of North Carolina Children's Specialty Clinic
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Prisma Health Children's Hospital - Midlands
Columbia, South Carolina, 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
Murdoch Children's Research Institute
Parkville, Victoria, Australia
Centre Hospitalier Universitaire d'Angers
Angers, France
Hôpital de la Timone - Enfants
Marseille, France
CHU de Toulouse - Hôpital des Enfants
Toulouse, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany
Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer
Florence, Florence, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Rome, Italy
IRCCS Istituto Giannina Gaslini
Genova, Italy
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, South Korea
Chungnam National University Sejong Hospital (CNUSH)
Sejong, South Korea