Ignite Creation Date:
2024-05-06 @ 12:04 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01488994
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2011-12-06
Brief Title:
BAX 326 Pediatric Study
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
BAX 326 Recombinant Factor IX A Phase 23 Prospective Uncontrolled Multicenter Study Evaluating Pharmacokinetics Efficacy Safety and Immunogenicity in Previously Treated Pediatric Patients With Severe FIX Level 1 or Moderately Severe FIX Level 1-2 Hemophilia B
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 study is to assess BAX 326 pharmacokinetic parameters to evaluate its hemostatic efficacy safety immunogenicity and changes in health-related quality of life in pediatric patients
Detailed Description:
The secondary outcome measure Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours h Post-infusion analysis was not done due to the different time-points for the last PK blood sample AUC0-72 h was redundant and only total AUC was included in the PK analysis
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 |
|---|---|---|---|
| 2011-002437-19 | EUDRACT_NUMBER | None | None |