Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484185
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2007-06-07
Brief Title:
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Post Marketing Surveillance To Observe Safety And Efficacy Of BeneFIX In Patients With Hemophilia B
Status:
COMPLETED
Status Verified Date:
2013-05
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:
To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations to identify any potential drug related treatment factors in Korean population including
1 Unknown adverse reactions especially serious adverse reactions 2 Changes in the incidences of adverse reactions under the routine drug uses
3 Factors that may affect the safety of the drug 4 Factors that may affect the effectiveness of the drug
1 Unknown adverse reactions especially serious adverse reactions 2 Changes in the incidences of adverse reactions under the routine drug uses
3 Factors that may affect the safety of the drug 4 Factors that may affect the effectiveness of the drug
Detailed Description:
The patients who meet the inclusion criteria will be enrolled consecutively
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 |
|---|---|---|---|
| B1821005 | None | None | None |