Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01599819
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2012-05-15
Brief Title:
BAX 855 Dose-Escalation Safety Study
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
BAX 855 PEGylated Recombinant Factor VIII A Phase 1 Prospective Open Label Cross-Over Dose-Escalation Study in Previously Treated Patients PTPs With Severe FVIII 1 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 objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients PTPs with severe hemophilia A to determine the pharmacokinetic PK parameters of BAX 855 compared in crossover with ADVATE and to evaluate the impact of anti-polyethylene glycol PEG antibodies on PK parameters
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 |
|---|---|---|---|
| 2011-002011-28 | EUDRACT_NUMBER | None | None |