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RIXUBIS Drug Use-Result Survey (Japan)

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ClinicalTrials.gov Identifier: NCT02937831
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief 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

Condition or disease Intervention/treatment
Hemophilia B Biological: RIXUBIS

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: RIXUBIS Drug Use-Result Survey (Japan)
Actual Study Start Date : November 16, 2016
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All Study Participants Biological: RIXUBIS
Other Names:
  • Coagulation Factor IX [Recombinant]
  • BAX 326
  • Recombinant factor IX
  • BAX326




Primary Outcome Measures :
  1. Number of participants who discontinued the use of Rixubis [ Time Frame: Throughout the study period, approximately 4 ½ years ]
  2. Number of participants who developed a Factor IX (FIX) inhibitor [ Time Frame: Throughout the study period, approximately 4 ½ years ]
  3. Annual bleed rate (ABR) of participants on a prophylaxis regimen [ Time Frame: Throughout the study period, approximately 4 ½ years ]
  4. Number of doses to treat a bleed of participants on an on-demand regimen [ Time Frame: At bleed resolution throughout the study period of approximately 4 ½ years ]
  5. Hemostatic effectiveness of Rixubis for participants on an on-demand regimen [ Time Frame: At bleed resolution throughout the study period of approximately 4 ½ years ]
    Based on a 4-point ordinal scale (none, moderate, good, excellent)

  6. Hemostatic effectiveness of Rixubis in surgery- perioperative and postoperative [ Time Frame: Assessed at the time of discharge from recovery room; and at 24 to 72 hours postoperatively ]
    Based on a 4-point ordinal scale (none, moderate, good, excellent)


Secondary Outcome Measures :
  1. Number of participants who experience shock or anaphylaxis [ Time Frame: Throughout the study period, approximately 4 ½ years ]
  2. Number of participants who experience a thromboembolism [ Time Frame: Throughout the study period, approximately 4 ½ years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who receive RIXUBIS in the actual clinical setting
Criteria

Inclusion Criteria:

  • Patients with hemophilia B scheduled to receive treatment with RIXUBIS

Exclusion Criteria:

  • Patients not administered RIXUBIS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937831


Contacts
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Contact: Claudia Schwarz, PhD claudia.schwarz@shire.com

Locations
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Japan
Seki-shi, Japan Recruiting
Seki-shi, Gifu Prefecture, Japan, 501-3802
Maebashi-shi, Japan Recruiting
Maebashi-shi, Gunma Prefecture, Japan, 371-8511
Nobeoka-shi, Japan Recruiting
Nobeoka-shi, Miyazaki Prefecture, Japan, 882-0835
Niigata-shi, Japan Recruiting
Niigata-shi, Niigata Prefecture, Japan, 950-0862
Osaka-shi, Japan Recruiting
Osaka-shi, Osaka Prefecture, Japan, 543-0001
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: Morio Arai, MD Baxalta now part of Shire

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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT02937831     History of Changes
Other Study ID Numbers: 251601
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked