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

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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Key information

Conditions

Hemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu Catholic University Medical Center, Daegu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

RIXUBIS

Biological

Recombinant Factor IX (rFIX) for intravenous use

Other names: Coagulation Factor IX [Recombinant], rFIX, BAX326, BAX 326

Primary outcomes

Number of adverse events (AEs)

Time frame: 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 outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

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

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

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Oct 4, 2016
Registry last updated: May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed