Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02210091
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2014-07-25
Brief Title:
BAX 855 Pediatric Study
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Prospective Uncontrolled Multicenter Study Evaluating Pharmacokinetics Efficacy Safety and Immunogenicity of BAX 855 PEGylated Full-length Recombinant FVIII in Previously Treated Pediatric 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:
The study purpose is
To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days EDs whichever occurs last
To compare pharmacokinetic PK parameters to ADVATE
To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes
To evaluate safety and immunogenicity
To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days EDs whichever occurs last
To compare pharmacokinetic PK parameters to ADVATE
To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes
To evaluate safety and immunogenicity
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 |
|---|---|---|---|
| 2014-000742-30 | EUDRACT_NUMBER | None | None |