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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-06

Study Completion Date

2019-04-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia B

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All Study Participants

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

RIXUBIS

Intervention Type BIOLOGICAL

Recombinant Factor IX (rFIX) for intravenous use

Interventions

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RIXUBIS

Recombinant Factor IX (rFIX) for intravenous use

Intervention Type BIOLOGICAL

Other Intervention Names

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Coagulation Factor IX [Recombinant] rFIX BAX326 BAX 326

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No