Brief Title
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Official Title
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Brief Summary
Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea. Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.
Study Type
Observational
Primary Outcome
Number of adverse events (AEs)
Secondary Outcome
Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old
Condition
Hemophilia B
Intervention
RIXUBIS
Study Arms / Comparison Groups
All Study Participants
Description: Participants with congenital hemophilia B (FIX level ≤5%)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
57
Start Date
January 6, 2017
Completion Date
April 4, 2019
Primary Completion Date
April 4, 2019
Eligibility Criteria
Inclusion Criteria: 1. Participants with congenital hemophilia B (FIX level ≤5%) 2. Participant or the participant's legally authorized representative has provided signed informed consent. 3. Participant is indicated for treatment according to the RIXUBIS Korean product leaflet. Exclusion Criteria: 1. Participants with known hypersensitivity or presence of any contraindication to RIXUBIS or its excipients including hamster protein 2. Participants with Disseminated Intravascular Coagulation (DIC) 3. Participants with signs of fibrinolysis
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02922231
Organization ID
251501
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
April 2021