A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature

Description

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), in children with idiopathic short stature (ISS).

Conditions

Idiopathic Short Stature

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Study Overview

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Study Details

Study overview

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), in children with idiopathic short stature (ISS).

A Phase 2, Randomized, Controlled, Multicenter Study of Vosoritide in Children With Idiopathic Short Stature

A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature

Condition
Idiopathic Short Stature
Intervention / Treatment

-

Contacts and Locations

Columbus

Centricity Research, Columbus, Georgia, United States, 31904

Boise

St. Luke's Children's Endocrinology, Boise, Idaho, United States, 83712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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
  • 2. Tanner Stage 1, at time of signing the ICF (unless too young to stage).
  • 1. Known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, Turner syndrome, disproportionate skeletal dysplasias, abnormal SHOX gene analysis, or Rasopathy (including Noonan syndrome)
  • 2. Previous treatment with a growth promoting agent

Ages Eligible for Study

3 Years to 10 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BioMarin Pharmaceutical,

Medical Director MD, STUDY_DIRECTOR, BioMarin Pharmaceutical

Study Record Dates

2036-12