Ignite Creation Date:
2024-05-05 @ 10:44 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01174446
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2010-08-02
Brief Title:
Pivotal Study Pharmacokinetics Efficacy Safety of BAX 326 rFIX in Hemophilia B Patients
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
Recombinant Factor IX BAX 326 A Phase 13 Prospective Controlled Multicenter Study Evaluating Pharmacokinetics Efficacy Safety and Immunogenicity in Previously Treated Patients With Severe or Moderately Severe 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 pivotal Phase 13 study is to determine the pharmacokinetic PK parameters the hemostatic efficacy and the safety of BAX 326 a recombinant factor IX in previously treated patients PTPs with severe and moderately severe hemophilia B
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 |
|---|---|---|---|
| 2009-016720-31 | EUDRACT_NUMBER | None | None |