Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06455059
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
Interventional Study of Vosoritide for the Treatment of Children With Hypochondroplasia
Sponsor:
BioMarin Pharmaceutical
Organization:
BioMarin Pharmaceutical
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Vosoritide in Children With Hypochondroplasia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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 intent and design of this Phase 3 study is to assess vosoritide as a therapeutic option for the treatment of children with hypochondroplasia HCH
Detailed Description:
This is a Phase 3 randomized stratified placebo-controlled double-blind multicenter study to evaluate the effect of 52 weeks of daily vosoritide administration on annualized growth velocity AGV in participants with HCH Eligible participants with documented HCH confirmed by genetic testing will roll over from Study 111-902 and enter the 111-303 study Participants will be randomly assigned to one of two treatment groups Placebo or Vosoritide The route of administration is subcutaneous injection and the frequency of administration is daily
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?:
None
Is an FDA AA801 Violation?:
None