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

Sponsor
Baxalta now part of Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT02922231
Collaborator
(none)
57
Enrollment
5
Locations
26.9
Actual Duration (Months)
11.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Biological: RIXUBIS

Study Design

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 :
Jan 6, 2017
Actual Primary Completion Date :
Apr 4, 2019
Actual Study Completion Date :
Apr 4, 2019

Arms and Interventions

Arm 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

    Primary Outcome Measures

    1. Number of adverse events (AEs) [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 [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 [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 [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 [Up to 6 months from baseline while on treatment]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Daegu Catholic University Medical Center Daegu Korea, Republic of 42472
    2 DaeJeon Eulji University Hospital Daejeon Korea, Republic of 35233
    3 Chung Hospital Gyeonggi-do Korea, Republic of 13316
    4 Kim Hugh Chul Internal Medicine Seoul Korea, Republic of 05538
    5 Korea Hemophilia Foundation Seoul Korea, Republic of 06641

    Sponsors and Collaborators

    • Baxalta now part of Shire

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baxalta now part of Shire
    ClinicalTrials.gov Identifier:
    NCT02922231
    Other Study ID Numbers:
    • 251501
    First Posted:
    Oct 4, 2016
    Last Update Posted:
    May 5, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Hemophilia A
    Hemophilia B

    Study Results

    No Results Posted as of May 5, 2021