Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775523
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-03-08
Brief Title:
A Post-Authorisation Safety Study PASS of Patients Treated With Lonapegsomatropin
Sponsor:
Ascendis Pharma Endocrinology Division AS
Organization:
Ascendis Pharma AS
Study Overview
Official Title:
A Prospective Non-interventional NIS Long-term Post-Authorisation Safety Study PASS of Patients Treated With Lonapegsomatropin
Status:
RECRUITING
Status Verified Date:
2024-01
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:
SkyPASS
Brief Summary:
The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None