A Phase 2, Randomized, Controlled, Multicenter Study of Vosoritide in Children With Idiopathic Short Stature
Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 11
Healthy Volunteers: f
View:
• 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 charts
• Tanner Stage 1, at time of signing the ICF (unless too young to stage).
Locations
United States
California
Children's Hospital of Orange County Main Campus - Orange
RECRUITING
California City
Consano Clinical Research, LLC
RECRUITING
California City
Rady Children's Hospital - San Diego
RECRUITING
California City
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Children's Hospital Oakland Research Institute
RECRUITING
Oakland
Center Of Excellence in Diabetes and Endocrinology
RECRUITING
Sacramento
Lundquist Institute for Biomedical Innovation (LA BioMed)
RECRUITING
Torrance
Washington, D.c.
The Children's National Research Institute
RECRUITING
Washington D.c.
Florida
Nemours Children's Specialty Care Jacksonville
RECRUITING
Jacksonville
Nicklaus Children's Hospital
RECRUITING
Miami
Optimal Research Sites
RECRUITING
Orange City
Nemours Children's Health System - Corporate Headquarters
RECRUITING
Pensacola
Georgia
Centricity Research
RECRUITING
Columbus
Iowa
University of Iowa Stead Family Children's Hospital
RECRUITING
Iowa City
Idaho
St. Luke's Children's Endocrinology
RECRUITING
Boise
Rocky Mountain Clinical Research - Idaho Falls
RECRUITING
Idaho Falls
Kentucky
Kentucky Children's Hospital
RECRUITING
Lexington
University of Louisville School of Medicine
RECRUITING
Louisville
Louisiana
Velocity Clinical Research - MedPharmics - Lafayette
RECRUITING
Lafayette
Ochsner Health Center for Children - New Orleans
WITHDRAWN
New Orleans
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
University of Minnesota Masonic Children's Hospital
RECRUITING
Minneapolis
North Carolina
University of North Carolina Children's Specialty Clinic
RECRUITING
Chapel Hill
New York
UBMD Pediatrics
RECRUITING
Buffalo
NYU Langone Ambulatory Care Garden City
WITHDRAWN
Garden City
Atlantic Health Children's Specialty Center at Morristown
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
The Clinical and Translational Science Institute
RECRUITING
New York
Children's Hospital at Montefiore
RECRUITING
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
South Carolina
Prisma Health Children's Hospital - Midlands
RECRUITING
Columbia
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Cook Children's Endocrinology
RECRUITING
Fort Worth
Baylor College of Medicine
RECRUITING
Houston
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Australia
Murdoch Children's Research Institute
RECRUITING
Parkville
France
Centre Hospitalier Universitaire d'Angers
RECRUITING
Angers
Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
Hôpital de la Timone - Enfants
RECRUITING
Marseille
CHU de Toulouse - Hôpital des Enfants
RECRUITING
Toulouse
Germany
Universitätsklinikum des Saarlandes
RECRUITING
Homburg
Italy
Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer
RECRUITING
Florence
IRCCS Istituto Giannina Gaslini
RECRUITING
Genova
Ospedale Pediatrico Bambino Gesù
RECRUITING
Roma
Republic of Korea
Inha University Hospital
RECRUITING
Incheon
Chungnam National University Sejong Hospital (CNUSH)
RECRUITING
Sejong
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Trial Specialist
medinfo@bmrn.com
+1 415.475.5852
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2036-12
Participants
Target number of participants: 100
Treatments
Experimental: Vosoritide Dose 1 - Low Dose
Vosoritide Dose 1 daily injection
Experimental: Vosoritide Dose 2 - Medium Dose
Vosoritide Dose 2 daily injection
Experimental: Vosoritide Dose 3 - High Dose
Vosoritide Dose 3 daily injection
Placebo_comparator: Placebo
Placebo daily injection
Active_comparator: Human Growth Hormone
hGH daily injection (US only)
Related Therapeutic Areas
Sponsors
Leads: BioMarin Pharmaceutical