Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01286779
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2011-01-26
Brief Title:
BAX 326 rFIX Continuation Study
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
BAX 326 Recombinant Factor IX Evaluation of Safety Immunogenicity and Hemostatic Efficacy in Previously Treated Patients With Severe FIX Level 1 or Moderately Severe FIX Level 2 Hemophilia B - A Continuation Study
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 purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time the hemostatic efficacy the safety immunogenicity and health-related quality of life HR QoL of BAX 326 in previously treated patients PTPs with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101
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 |
|---|---|---|---|
| 2010-022726-33 | EUDRACT_NUMBER | None | None |