Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02716194
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2016-03-17
Brief Title:
BAX 826 Dose-Escalation Safety Study
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 1 Prospective Open Label Two Period Fixed Sequence Dose-Escalation Study of the PK and Safety of BAX 826 PSA-rFVIII in Previously Treated Patients With Severe FVIII 1 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:
None
Brief Summary:
1 To assess tolerability and safety of BAX 826 after a single infusion in previously treated patients PTPs with severe hemophilia A
2 To determine the pharmacokinetic PK parameters of BAX 826 compared to ADVATE
3 To evaluate immunogenicity of polysialic acid linked to Factor VIII FVIII
2 To determine the pharmacokinetic PK parameters of BAX 826 compared to ADVATE
3 To evaluate immunogenicity of polysialic acid linked to Factor VIII FVIII
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 |
|---|---|---|---|
| 2015-004079-60 | EUDRACT_NUMBER | None | None |