ADYNOVATE Drug Use-Results Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 49
- 主要终点
- Number of Participants Who Discontinued the Use of Study Drug
研究概览
简要总结
The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients:
- Unexpected adverse drug reactions
- Occurrence of adverse drug reactions in the actual clinical use
- Factors that may affect safety and efficacy
- Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A)
- Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy
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
- •Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE.
排除标准
- •Patients not administered ADYNOVATE.
研究组 & 干预措施
Previously treated patients (PTPs)
PTPs: patients who had 4 or more days to other Factor VIII (FVIII) products
干预措施: ADYNOVATE (Biological)
Previously untreated patients (PUPs)
PUPs: patients who had 3 or less previous exposure days to other products
干预措施: ADYNOVATE (Biological)
结局指标
主要结局
Number of Participants Who Discontinued the Use of Study Drug
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Number of previously treated patients (PTPs) and previously untreated patients (PUPs) who discontinued the use of ADYNOVATE were reported.
Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Annual bleed rate (ABR) of spontaneous bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425.
Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Annual bleed rate (ABR) of breakthrough bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425.
Duration of Treatment of Study Drug on a Prophylaxis Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs.
Duration of treatment of study drug on a prophylaxis regimen was reported.
Duration of Treatment of Study Drug an On-Demand Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Duration of treatment of study drug on an on-demand regimen was reported.
Dose Per Administration of Study Drug on a Prophylaxis Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Dose per administration of study drug on a prophylaxis regimen was reported.
Dose Per Administration of Study Drug an On-Demand Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Dose per administration of study drug on an on-demand regimen was reported.
Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Number of doses per a bleeding episode of study drug on an on-demand regimen was reported.
Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Percentage of each category of hemostatic effectiveness for treatment of breakthrough bleeding episodes in a prophylaxis regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor.
Hemostatic Effectiveness of Study Drug on an On-Demand Regimen
时间窗: Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs
Percentage of each category of hemostatic effectiveness for an on-demand regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor.
次要结局
- Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen(Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs)
- Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE)(Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs)