Hemophilia BNCT02922231
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
An observational study of Hemophilia B, run by Baxalta now part of Shire at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia B
- What is being tested?
- RIXUBIS
- Type of treatment
- Injection or infusion
- How many people
- 57 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 6 Jan 2017to 4 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hemophilia B in South Korea who have been prescribed RIXUBIS.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Daegu Catholic University Medical Center
Daegu, 42472
DaeJeon Eulji University Hospital
Daejeon, 35233
Chung Hospital
Gyeonggi-do, 13316
Kim Hugh Chul Internal Medicine
Seoul, 05538
Korea Hemophilia Foundation
Seoul, 06641
About this study
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.
- Conditions
- Hemophilia B
- Being tested
- RIXUBIS
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIXUBISBiological
Also called Coagulation Factor IX [Recombinant], rFIX, BAX326, BAX 326
Recombinant Factor IX (rFIX) for intravenous use
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Participants with congenital hemophilia B (FIX level ≤5%) Receives: Biological: RIXUBIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs)
Seriousness and severity of AEs, including any inhibitory antibody development and/or anaphylactic reactions
Measured: 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
Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none
Measured: Up to 6 months from baseline while on treatment
Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old
Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none
Measured: Up to 6 months from baseline while on treatment
Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old
Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none
Measured: Up to 6 months from baseline while on treatment
Participant rated effectiveness of RIXUBIS for on-demand treatment in participants ≥12 years old
Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none
Measured: Up to 6 months from baseline while on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start6 Jan 2017
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922231
- Sponsor's protocol ID
- 251501
- Status last verified
- Apr 2021
- First submitted
- 30 Sep 2016
- Last updated
- 5 May 2021
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
- ClinicalTrials.gov ID
- NCT02922231
- Acronym / sponsor ID
- 251501
- Conditions
- Hemophilia B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | – | Biological: RIXUBISParticipants with congenital hemophilia B (FIX level ≤5%) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hemophilia B in South Korea who have been prescribed RIXUBIS.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIXUBISAlso: Coagulation Factor IX [Recombinant], rFIX, BAX326, BAX 326Recombinant Factor IX (rFIX) for intravenous use | Biological | All Study Participants |
Primary outcome
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
4 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
Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old
Time frame: Up to 6 months from baseline while on treatment
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Hemophilia B
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia B, run by Baxalta now part of Shire at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (AEs) (time frame: Throughout the study period of approximately 2 years and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.