Ignite Creation Date:
2024-05-06 @ 1:59 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01945593
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2013-09-16
Brief Title:
BAX 855 Continuation
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 3b Continuation Study of the Safety and Efficacy of PEGylated Recombinant Factor VIII PEG-rFVIII BAX 855 in Prophylaxis of Bleeding in Previously Treated Patients With Severe Hemophilia A
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:
To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients PTPs aged 75 years of age with severe hemophilia A
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-002236-24 | EUDRACT_NUMBER | None | None |