Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606314
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Specified Drug-use Surveillance of Fabhalta Capsules
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Specified Drug-use Surveillance of Fabhalta Capsules Paroxysmal Nocturnal Hemoglobinuria CLNP023C11401
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter single-arm non-interventional study NIS with a central registration system and an all-case surveillance system The observation period is 48 weeks after the start of treatment with Fabhalta
Detailed Description:
The observation period will be 48 weeks after the start of treatment with Fabhalta
For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment adverse events occurring by the last day of the treatment 30 days and concomitant drugs will be monitored and recorded in CRFs
For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment adverse events occurring by the last day of the treatment 30 days and concomitant drugs will be monitored and recorded in CRFs
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: