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Completed

NCT Number: NCT02937831

RIXUBIS Drug Use-Result Survey (Japan)

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

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Key information

Conditions

Hemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Seki-shi, Japan, Seki-shi, Gifu, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hemophilia B scheduled to receive treatment with RIXUBIS

Exclusion criteria

  • Patients not administered RIXUBIS

Treatment and study plan

RIXUBIS

Biological

Other names: Coagulation Factor IX [Recombinant], BAX 326, Recombinant factor IX, BAX326

Primary outcomes

  1. Number of Participants Who Discontinued the Use of Nonacog Gamma (Genetical Recombination)

    Time frame: 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.

  2. Number of Participants Who Developed a Factor IX (FIX) Inhibitor

    Time frame: Throughout the study period, approximately 4 ½ years

    Number of participants who developed a Factor IX (FIX) Inhibitor was reported in this outcome measure.

  3. Annual Bleed Rate (ABR): Number of Times of Bleeding During the Study

    Time frame: 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.

  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

    Number of doses to treat a bleed of participants on an on-demand regimen was reported in this outcome measure.

  5. Hemostatic Effectiveness of Rixubis for Participants on An On-Demand Regimen Based on a 4-Point Ordinal Scale (Excellent, Moderate, Good, Poor)

    Time frame: 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.

  6. 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

    Time frame: 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.

Secondary outcomes

  1. Number of Participants Who Experienced Adverse Events of Shock or Anaphylaxis

    Time frame: 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.

  2. Number of Participants Who Experienced Adverse Events of Thromboembolism

    Time frame: Throughout the study period, approximately 4 ½ years

    Number of participants who experienced adverse events of thromboembolism was reported in this outcome measure.

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Collaborators

  • Takeda

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2016
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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