Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2026-03-06 @ 2:55 PM
Study NCT ID:
NCT02055157
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2013-04-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia
Sponsor:
BioMarin Pharmaceutical
Organization:
Study Overview
Official Title:
A Phase 2, Open-label, Sequential Cohort Dose-escalation Study of BMN 111 in Children With Achondroplasia
Status:
COMPLETED
Status Verified Date:
2020-12
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:
ACH
Brief Summary:
This is a Phase 2, open-label, sequential cohort dose-escalation study of BMN 111 in children with achondroplasia. The primary objective is to assess the safety and tolerability of daily BMN 111 administered to children with achondroplasia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-004137-32 | EUDRACT_NUMBER | None | View |