Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
- Conditions
- Hemophilia B
- Interventions
- Biological: RIXUBIS
- Registration Number
- NCT02922231
- Lead Sponsor
- Baxalta now part of Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- Participants with congenital hemophilia B (FIX level ≤5%)
- Participant or the participant's legally authorized representative has provided signed informed consent.
- Participant is indicated for treatment according to the RIXUBIS Korean product leaflet.
- Participants with known hypersensitivity or presence of any contraindication to RIXUBIS or its excipients including hamster protein
- Participants with Disseminated Intravascular Coagulation (DIC)
- Participants with signs of fibrinolysis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All Study Participants RIXUBIS Participants with congenital hemophilia B (FIX level ≤5%)
- Primary Outcome Measures
Name Time Method Number of adverse events (AEs) Throughout the study period of approximately 2 years and 6 months Seriousness and severity of AEs, including any inhibitory antibody development and/or anaphylactic reactions
- Secondary Outcome Measures
Name Time Method Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old Up to 6 months from baseline while on treatment Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none
Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old Up to 6 months from baseline while on treatment Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none
Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old Up to 6 months from baseline while on treatment Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none
Participant rated effectiveness of RIXUBIS for on-demand treatment in participants ≥12 years old Up to 6 months from baseline while on treatment Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none
Trial Locations
- Locations (5)
Kim Hugh Chul Internal Medicine
🇰🇷Seoul, Korea, Republic of
Korea Hemophilia Foundation
🇰🇷Seoul, Korea, Republic of
Chung Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
DaeJeon Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of