Vonvendi Intravenous Specified Drug Use-results Survey "Pediatric Administration"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs)
研究概览
简要总结
This study is conducted in Japan of vonicog alfa (rVWF) used to treat pediatric participants with Von Willebrand Disease (vWD).
The main aim of the study is to evaluate adverse drug reaction and effectiveness of vonicog alfa (rVWF).
During the study, pediatric participants with vWD will be administered with rVWF under routine normal practice. The investigators will evaluate adverse events due to rVWF for 1 year from the start of drug administration.
The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under 18 years old with vWD.
- •Participants who are treated with rVWF for the purpose of hemostatic treatment and management during bleeding episodes or perioperative periods.
- •Participants who have prescription or administration after the approval date of rVWF for pediatric use in Japan.
排除标准
- •- Patients who are participating in clinical trials of rVWF.
研究组 & 干预措施
vonicog alfa (rVWF) Group
Participants with Von Willebrand Disease (vWD) who received vonicog alfa (rVWF) in accordance with package insert.
干预措施: vonicog alfa (rVWF) (Drug)
结局指标
主要结局
Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs)
时间窗: Up to 1 year
Adverse Event (AE) refers to any undesirable medical occurrence in a patient administered a drug, regardless of causal relationship. This includes any unfavorable or unintended sign (including abnormal laboratory findings), symptom, or disease occurring during administration, regardless of causal relationship. Adverse drug reaction (ADR) refers to AE related to administered drug.
次要结局
- Hemostatic Efficacy Assessed by Hemostatic Efficacy Rating Scale(1 year)
- Hemostatic Efficacy during Perioperative Periods Assessed by Hemostatic Efficacy Rating Scale(1 year)
- Number of Infusions per Bleeding Episode(1 year)
- Number of Infusions during Perioperative Periods(1 year)