Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01507896
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2012-01-09
Brief Title:
BAX 326 Surgery Study in Hemophilia B Patients
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
BAX 326 Recombinant Factor IX A Phase 3 Prospective Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe FIX Level 1 or Moderately Severe FIX Level 1-2 Hemophilia B Undergoing Surgical or Other Invasive Procedures
Status:
COMPLETED
Status Verified Date:
2021-04
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 purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in subjects with severe FIX level 1 or moderately severe FIX level 1-2 hemophilia B undergoing major or minor elective or emergency surgical dental or other invasive procedures
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-000413-39 | EUDRACT_NUMBER | None | None |