Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459641
Status:
WITHDRAWN
Last Update Posted:
2012-07-17
First Post:
2007-04-11
Brief Title:
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
Sponsor:
Kuros Biosurgery AG
Organization:
Kuros Biosurgery AG
Study Overview
Official Title:
A Phase 2 Randomised Open-label Multi-centre Ascending Dose Study of the Efficacy Safety and Tolerability of I-040302 Versus Control Injection Bone Marrow Aspirate or Steroids in Children and Young Adults With Solitary Bone Cysts
Status:
WITHDRAWN
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped before any site initiation or any recruitment due to change in overall product development plan
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomised controlled open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection methylprednisolone Subjects will undergo screening with X-ray and magnetic resonance imaging MRI in the diagnosis of a solitary bone cyst
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None