Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
1 other identifier
observational
57
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Start
First participant enrolled
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2019
CompletedMay 5, 2021
April 1, 2021
2.2 years
September 30, 2016
April 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of adverse events (AEs)
Seriousness and severity of AEs, including any inhibitory antibody development and/or anaphylactic reactions
Throughout the study period of approximately 2 years and 6 months
Secondary Outcomes (4)
Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old
Up to 6 months from baseline while on treatment
Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old
Up to 6 months from baseline while on treatment
Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old
Up to 6 months from baseline while on treatment
Participant rated effectiveness of RIXUBIS for on-demand treatment in participants ≥12 years old
Up to 6 months from baseline while on treatment
Study Arms (1)
All Study Participants
Participants with congenital hemophilia B (FIX level ≤5%)
Interventions
Recombinant Factor IX (rFIX) for intravenous use
Eligibility Criteria
Patients with hemophilia B in South Korea who have been prescribed RIXUBIS.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
DaeJeon Eulji University Hospital
Daejeon, 35233, South Korea
Chung Hospital
Gyeonggi-do, 13316, South Korea
Kim Hugh Chul Internal Medicine
Seoul, 05538, South Korea
Korea Hemophilia Foundation
Seoul, 06641, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2016
First Posted
October 4, 2016
Study Start
January 6, 2017
Primary Completion
April 4, 2019
Study Completion
April 4, 2019
Last Updated
May 5, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. 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.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.