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NCT02937831 Clinical Trial

RIXUBIS Drug Use-Result Survey (Japan)

Hemophilia B Clinical Trial

Official title:
RIXUBIS Drug Use-Result Survey (Japan)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02937831
Other study ID # 251601
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2016
Est. completion date May 11, 2022

Study information
Verified date July 2022
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date May 11, 2022
Est. primary completion date May 11, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with hemophilia B scheduled to receive treatment with RIXUBIS Exclusion Criteria: - Patients not administered RIXUBIS

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• RIXUBIS

Locations
Country Name City State
Japan Maebashi-shi, Japan Maebashi-shi Gunma Prefecture
Japan Niigata-shi, Japan Niigata-shi Niigata Prefecture
Japan Nobeoka-shi, Japan Nobeoka-shi Miyazaki Prefecture
Japan Osaka-shi, Japan Osaka-shi Osaka Prefecture
Japan Seki-shi, Japan Seki-shi Gifu Prefecture

Sponsors (2)
Lead Sponsor Collaborator
Baxalta now part of Shire Takeda

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants who discontinued the use of Rixubis Throughout the study period, approximately 4 ½ years
Primary Number of participants who developed a Factor IX (FIX) inhibitor Throughout the study period, approximately 4 ½ years
Primary Annual bleed rate (ABR) of participants on a prophylaxis regimen Throughout the study period, approximately 4 ½ years
Primary Number of doses to treat a bleed of participants on an on-demand regimen At bleed resolution throughout the study period of approximately 4 ½ years
Primary Hemostatic effectiveness of Rixubis for participants on an on-demand regimen Based on a 4-point ordinal scale (none, moderate, good, excellent) At bleed resolution throughout the study period of approximately 4 ½ years
Primary Hemostatic effectiveness of Rixubis in surgery- perioperative and postoperative Based on a 4-point ordinal scale (none, moderate, good, excellent) Assessed at the time of discharge from recovery room; and at 24 to 72 hours postoperatively
Secondary Number of participants who experience shock or anaphylaxis Throughout the study period, approximately 4 ½ years
Secondary Number of participants who experience a thromboembolism Throughout the study period, approximately 4 ½ years
See also
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