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

Baxalta now part of Shire57 enrolled

Overview

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

Enrollment

Conditions

Hemophilia B

Interventions

RIXUBISBIOLOGICAL

Recombinant Factor IX (rFIX) for intravenous use

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (5)

Daegu Catholic University Medical Center

Daegu, South Korea

DaeJeon Eulji University Hospital

Daejeon, South Korea

Chung Hospital

Gyeonggi-do, South Korea

Kim Hugh Chul Internal Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

Number of adverse events (AEs)

Seriousness and severity of AEs, including any inhibitory antibody development and/or anaphylactic reactions

Time frame: Throughout the study period of approximately 2 years and 6 months

Secondary Outcomes

Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old

Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none

Time frame: Up to 6 months from baseline while on treatment

Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old

Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none

Time frame: Up to 6 months from baseline while on treatment

Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old

Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none

Time frame: Up to 6 months from baseline while on treatment

Participant rated effectiveness of RIXUBIS for on-demand treatment in participants ≥12 years old

Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none

Time frame: Up to 6 months from baseline while on treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.