Ignite Creation Date:
2024-05-06 @ 9:05 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02895945
Status:
TERMINATED
Last Update Posted:
2021-10-20
First Post:
2016-08-15
Brief Title:
BAX 802 in CHA With Inhibitors
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Multicenter Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII BAX 802 in Subjects With Congenital Hemophilia A With Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Takeda has determined that the benefitrisk profile does not support continuation of the surgery Study for this specific Congenital Hemophilia A with Inhibitors patient population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAWI
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A CHA with inhibitors who are undergoing major or minor elective surgical dental or other invasive procedures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2015-005521-39 | EUDRACT_NUMBER | None | None |