Hemophilia B
Conditions
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.
Interventions
BIOLOGICALRIXUBIS
Recombinant Factor IX (rFIX) for intravenous use
Sponsors
Baxalta now part of Shire
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed