RIXUBIS Drug Use-Result Survey (Japan)

Completed

Conditions: Hemophilia B

Interventions: Biological: RIXUBIS

Registration Number: NCT02937831

Lead Sponsor: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6

Inclusion Criteria

Patients with hemophilia B scheduled to receive treatment with RIXUBIS

Exclusion Criteria

Patients not administered RIXUBIS

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Study Participants	RIXUBIS	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Discontinued the Use of Nonacog Gamma (Genetical Recombination)	Throughout the study period, approximately 4 ½ years	Number of participants who discontinued the use of Nonacog Gamma (Genetical Recombination) was reported in this outcome measure.
Number of Participants Who Developed a Factor IX (FIX) Inhibitor	Throughout the study period, approximately 4 ½ years	Number of participants who developed a Factor IX (FIX) Inhibitor was reported in this outcome measure.
Hemostatic Effectiveness of Rixubis in Surgery-Perioperative and Postoperative Based on a 4-Point Ordinal Scale (Excellent, Moderate, Good, Poor) for Participants Who Received Perioperative Therapy During the Study	Assessed at the time of discharge from recovery room; and at 24 to 72 hours postoperatively	Number of participants in hemostatic effectiveness of Rixubis with a 4-point ordinal scale (Excellent, Moderate, Good, Poor) for perioperative therapy was reported in this outcome measure. The definition of each scale was following: Excellent; Amount of bleeding is smaller than expected. Good; Amount of bleeding is within the expected range. Fair; Amount of bleeding is greater than expected, with use of additional concomitant medication. Poor; Hemostasis difficulty.
Hemostatic Effectiveness of Rixubis for Participants on An On-Demand Regimen Based on a 4-Point Ordinal Scale (Excellent, Moderate, Good, Poor)	At bleed resolution throughout the study period of approximately 4 ½ years	Number of participants in hemostatic effectiveness of Rixubis with a 4-point ordinal scale (Excellent, Moderate, Good, Poor) for an on-demand regimen was reported in this outcome measure. The definition of each scale was following: Excellent; After a single infusion, complete disappearance of pain and objective decrease of bleeding symptom (swelling, tenderness, and increase in range of motion in musculoskeletal bleeding case) were observed. Good; After a single infusion, there were definitive relief of pain and improvement of bleeding symptom. Fair; After a single infusion, there were a probable or slight relief of pain and a mild improvement of bleeding signs. Poor; Improvement was not observed or symptom was aggravated.
Annual Bleed Rate (ABR): Number of Times of Bleeding During the Study	Throughout the study period, approximately 4 ½ years	Annual bleed rate (ABR) was defined as the number of times of bleeding during the study. ABR was reported in this outcome measure.
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	Number of doses to treat a bleed of participants on an on-demand regimen was reported in this outcome measure.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Adverse Events of Thromboembolism	Throughout the study period, approximately 4 ½ years	Number of participants who experienced adverse events of thromboembolism was reported in this outcome measure.
Number of Participants Who Experienced Adverse Events of Shock or Anaphylaxis	Throughout the study period, approximately 4 ½ years	Number of participants who experienced adverse events of shock or anaphylaxis was reported in this outcome measure.

Trial Locations

Locations (5): Seki-shi, Japan
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Seki-shi, Gifu Prefecture, Japan
Nobeoka-shi, Japan
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Nobeoka-shi, Miyazaki Prefecture, Japan
Osaka-shi, Japan
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Osaka-shi, Osaka Prefecture, Japan
Maebashi-shi, Japan
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Maebashi-shi, Gunma Prefecture, Japan
Niigata-shi, Japan
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Niigata-shi, Niigata Prefecture, Japan