RIXUBIS Drug Use-Result Survey (Japan)

  • STATUS
    Recruiting
  • End date
    May 31, 2022
  • participants needed
    30
  • sponsor
    Baxalta now part of Shire
Updated on 27 January 2021
deficiency
hemophilia
rixubis

Summary

The purpose of this survey is to understand the following items observed in the actual clinical use of RIXUBIS.

  1. Unexpected adverse drug reactions
  2. Occurrence of adverse drug reactions in the actual clinical use
  3. Factors that may affect safety and effectiveness
  4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency
  5. Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy

Details
Condition Factor IX Deficiency, christmas disease
Treatment RIXUBIS
Clinical Study IdentifierNCT02937831
SponsorBaxalta now part of Shire
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with hemophilia B scheduled to receive treatment with RIXUBIS

Exclusion Criteria

Patients not administered RIXUBIS
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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