Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382155
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-19
Brief Title:
A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature
Sponsor:
BioMarin Pharmaceutical
Organization:
BioMarin Pharmaceutical
Study Overview
Official Title:
A Phase 2 Randomized Controlled Multicenter Study of Vosoritide in Children With Idiopathic Short Stature
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 in children with idiopathic short stature ISS
Detailed Description:
Following a minimum 6 month observational period in which baseline growth is assessed participants in the vosoritide and placebo groups will complete a minimum of 6 months of randomized treatment maximum of 6 months of placebo treatment followed by open-label treatment with vosoritide until they reach near-final adult height or at least 16 years of age for females or 18 years of age for males whichever comes later Participants randomized to the hGH group will receive open-label hGH for a minimum of 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None