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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922231
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Tracking Information
First Submitted Date September 30, 2016
First Posted Date October 4, 2016
Last Update Posted Date May 5, 2021
Actual Study Start Date January 6, 2017
Actual Primary Completion Date April 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 30, 2016)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Official Title Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with hemophilia B in South Korea who have been prescribed RIXUBIS.
Condition Hemophilia B
Intervention Biological: RIXUBIS
Recombinant Factor IX (rFIX) for intravenous use
Other Names:
  • Coagulation Factor IX [Recombinant]
  • rFIX
  • BAX326
  • BAX 326
Study Groups/Cohorts All Study Participants
Participants with congenital hemophilia B (FIX level ≤5%)
Intervention: Biological: RIXUBIS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2019)
57
Original Estimated Enrollment
 (submitted: September 30, 2016)
600
Actual Study Completion Date April 4, 2019
Actual Primary Completion Date April 4, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02922231
Other Study ID Numbers 251501
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (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.
URL: https://vivli.org/ourmember/takeda/
Responsible Party Takeda ( Baxalta now part of Shire )
Study Sponsor Baxalta now part of Shire
Collaborators Not Provided
Investigators
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date April 2021