Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 120
- 试验地点
- 24
- 主要终点
- Incidence of Adverse Drug Reactions (ADRs) (%)
研究概览
简要总结
This is an observational study, hence there is no study hypothesis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of von Willebrand Disease who have been prescribed Wilate
排除标准
- 未提供
结局指标
主要结局
Incidence of Adverse Drug Reactions (ADRs) (%)
时间窗: Throughout the duration of each patient's participation in the study (mean [± standard deviation (SD)]: 575 days [±326]; median [range]: 731 days [2-1185])
Medical Dictionary for Regulatory Activities (MedDRA) primary system organ class preferred term. Incidence rate = number of patients reporting the event / number of patients \* 100
Tolerability Assessment of Wilate Infusions by Reason for Administration
时间窗: During and immediately after each infusion of Wilate during the study.
Tolerability was assessed using a 3-point verbal rating scale (excellent; satisfactory; unsatisfactory) according to overall feeling during and after Wilate therapy and occurrence of ADRs. Tolerability was assessed for infusions given for on-demand and prophylactic treatment, but not for infusions administered for surgeries or for the purpose of thrombogenicity assessment. In some instances, however, investigators also recorded the tolerability of infusions given for surgical prophylaxis. For infusions administered for surgeries, only those with available tolerability assessments are presented. Wilate infusion may have been administered to a patient for more than one reason and may be included in more than one category (e.g., if a patient was under Wilate prophylaxis, they could also receive Wilate for the treatment of a bleeding episode \[BE\] or surgery or menstruation).
次要结局
- Patient and Investigator Efficacy Analysis Assessment of the Treatment of Bleeding Episodes (BEs)(During and immediately after treatment of each BE.)
- Efficacy Analysis for the Prevention of Breakthrough Bleeds During Prophylaxis(At the end of the study for each patient (study duration: mean [±SD]: 805 days [±247]; median [range]: 797 days [144-1185]).)
- Efficacy Analysis of Surgical Prophylaxis(During and immediately after each surgery.)
- Overall Efficacy Assessment by Patient and Physician at the End of the Treatment Period(At the end of the study for each patient (study duration: mean [±SD]: 596 days [±336]; median [range]: 732 days [2-1185]).)