Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550882
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
A Study of OBIZUR in Adults With Acquired Hemophilia A AHA in South Korea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post-Marketing Surveillance Use-result Surveillance of OBIZUR Injection Susoctocog Alpha Porcine Antihemophilic Factor VIII Recombinant for the Approved Indications in South Korea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acquired hemophilia A AHA is a rare bleeding condition which prevents blood clotting Acquired means that people are not born with this condition or have a family history of blood clotting conditions People living with AHA can have sudden and severe bleeding They also have longer bleeding compared to people without AHA
The main aim of the study is to learn how safe OBIZUR is in adults with AHA
Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting
The treatment of the participants will be determined by the treating physicians
During the study data already existing in the participants medical record and new data will be collected
The main aim of the study is to learn how safe OBIZUR is in adults with AHA
Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting
The treatment of the participants will be determined by the treating physicians
During the study data already existing in the participants medical record and new data will be collected
Detailed Description:
This is a prospective and retrospective multicenter single-arm non-interventional post-marketing surveillance study
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