Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea

Baxalta

Status: Completed

Conditions: Hemophilia B

Treatments: Biological: RIXUBIS

Study type: Observational

Funder types: Industry

Identifiers

NCT02922231

251501

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

57 participants in 1 patient group

All Study Participants

Description:

Participants with congenital hemophilia B (FIX level ≤5%)

Treatment:

Biological: RIXUBIS