Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783428
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2021-02-18
Brief Title:
Tumor-induced Osteomalacia Disease Monitoring Program
Sponsor:
Ultragenyx Pharmaceutical Inc
Organization:
Ultragenyx Pharmaceutical Inc
Study Overview
Official Title:
Tumor-induced Osteomalacia Disease Monitoring Program TIO DMP
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 objectives of this observational study are to assess the long-term safety and long-term effectiveness of burosumab in patients with TIO who are being treated with burosumab as prescribed by their physician and to monitor the course of the underlying phosphaturic mesenchymal tumor PMT overtime in patients with TIO irrespective of their treatment status
Detailed Description:
Enrolled patients may or may not be treated with commercially available burosumab during the TIO DMP at the discretion of their treating physician Given the observational nature of the TIO DMP specific treatments or supportive management will not be provided as part of the study
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