Ignite Creation Date:
2024-05-06 @ 7:41 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02585960
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2015-10-21
Brief Title:
BAX 855 PK-guided Dosing
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
Phase 3 Prospective Randomized Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A
Status:
COMPLETED
Status Verified Date:
2021-05
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:
PROPEL
Brief Summary:
1 To compare the efficacy and safety of pharmacokinetic PK-guided treatment with BAX 855 targeting FVIII trough levels of 1-3 and approximately 10 8-12
2 To further characterize pharmacokinetic PK and pharmacodynamic PD parameters of BAX 855
2 To further characterize pharmacokinetic PK and pharmacodynamic PD 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 |
|---|---|---|---|
| 2014-005477-37 | EUDRACT_NUMBER | None | None |