BENEFIX(REGISTERED) INTRAVENOUS 500 1000 2000 DRUG USE RESULTS SURVEY (ALL-CASE SURVEILLANCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy
研究概览
简要总结
The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch.
- Occurrence status of adverse events
- Factors that may influence the safety
- Efficacy In addition, the following occurrence statuses will be investigated as priority items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic reaction, and Thrombosis.
详细描述
Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.
Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs").
The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with hemophilia B scheduled to receive treatment with BeneFIX will be eligible for the surveillance.
- •No patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected.
排除标准
- •Patients not administered BeneFIX.
研究组 & 干预措施
Nonacog Alfa (Genetical Recombination)
干预措施: Nonacog Alfa (Genetical Recombination) (Drug)
结局指标
主要结局
Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy
时间窗: 2 years for PTPs, 1 year for PUPs
Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing.
Number of Administrations Required for Hemostasis for Bleeding Events
时间窗: 2 years for PTPs, 1 year for PUPs
Mean number of administrations for hemostasis in replacement therapy for bleeding events.
次要结局
- Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes(2 years for PTPs, 1 year for PUPs)