Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-28 @ 7:19 PM
Study NCT ID:
NCT01386268
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2011-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kogenate FS Regulatory Post-Marketing Surveillance
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
KOGENATE® FS , Local Post Authorization Safety Study
Status:
COMPLETED
Status Verified Date:
2014-08
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:
KG0910KR
Brief Summary:
To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.
The observation period for each patient is up to 6 months.
The observation period for each patient is up to 6 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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 |
|---|---|---|---|---|
| KG0910KR | OTHER | Company Internal | View |