Ignite Creation Date:
2024-05-06 @ 1:07 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01736475
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2012-11-21
Brief Title:
Study Investigating a PEGylated Recombinant Factor VIII BAX 855 for Hemophilia A PROLONG-ATE Study
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 23 Multi-Center Open Label Study of Efficacy Safety and Pharmacokinetics of PEGylated Recombinant Factor VIII BAX 855 Administered for Prophylaxis and Treatment 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 assess efficacy and safety including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent 12-65 years previously treated patients PTPs with severe hemophilia A To determine the pharmacokinetic PK parameters of BAX 855
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 |
|---|---|---|---|
| 2012-003599-38 | EUDRACT_NUMBER | None | None |