Brief Title
RIXUBIS Drug Use-Result Survey (Japan)
Official Title
RIXUBIS Drug Use-Result Survey (Japan)
Brief Summary
The purpose of this survey is to understand the following items observed in the actual clinical use of RIXUBIS. 1. Unexpected adverse drug reactions 2. Occurrence of adverse drug reactions in the actual clinical use 3. Factors that may affect safety and effectiveness 4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency 5. Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy
Study Type
Observational
Primary Outcome
Number of participants who discontinued the use of Rixubis
Secondary Outcome
Number of participants who experience shock or anaphylaxis
Condition
Hemophilia B
Intervention
RIXUBIS
Study Arms / Comparison Groups
All Study Participants
Description:
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
2
Start Date
November 16, 2016
Completion Date
May 11, 2022
Primary Completion Date
May 11, 2022
Eligibility Criteria
Inclusion Criteria: - Patients with hemophilia B scheduled to receive treatment with RIXUBIS Exclusion Criteria: - Patients not administered RIXUBIS
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT02937831
Organization ID
251601
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Collaborators
Takeda
Study Sponsor
Study Director, Study Director, Shire
Verification Date
July 2022