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

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ClinicalTrials.gov Identifier: NCT02922231
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Study Description
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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.


Condition or disease Intervention/treatment
Hemophilia B Biological: RIXUBIS

Study Design
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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : April 4, 2019
Actual Study Completion Date : April 4, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
All Study Participants
Participants with congenital hemophilia B (FIX level ≤5%)
 Biological: RIXUBIS
Recombinant Factor IX (rFIX) for intravenous use
Other Names:
  • Coagulation Factor IX [Recombinant]
  • rFIX
  • BAX326
  • BAX 326


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hemophilia B in South Korea who have been prescribed RIXUBIS.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922231


Locations
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Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of, 42472
DaeJeon Eulji University Hospital
Daejeon, Korea, Republic of, 35233
Chung Hospital
Gyeonggi-do, Korea, Republic of, 13316
Kim Hugh Chul Internal Medicine
Seoul, Korea, Republic of, 05538
Korea Hemophilia Foundation
Seoul, Korea, Republic of, 06641
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: Study Director Shire
More Information
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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT02922231    
Other Study ID Numbers: 251501
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked