RIXUBIS Drug Use-Result Survey (Japan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 5
- 主要终点
- Annual Bleed Rate (ABR): Number of Times of Bleeding During the Study
研究概览
简要总结
The purpose of this survey is to understand the following items observed in the actual clinical use of RIXUBIS.
- Unexpected adverse drug reactions
- Occurrence of adverse drug reactions in the actual clinical use
- Factors that may affect safety and effectiveness
- Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency
- Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hemophilia B scheduled to receive treatment with RIXUBIS
排除标准
- •Patients not administered RIXUBIS
结局指标
主要结局
Annual Bleed Rate (ABR): Number of Times of Bleeding During the Study
时间窗: 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
时间窗: 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.
Number of Participants Who Discontinued the Use of Nonacog Gamma (Genetical Recombination)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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 Shock or Anaphylaxis(Throughout the study period, approximately 4 ½ years)