Adynovate Special Drug Use Result Survey (Perioperative Administration)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study is about a factor VIII medicine called Adynovate (TAK-660) used during surgery for people with hemophilia A who have low blood levels of factor VIII.
The aims of this study are as follows:
- To check for side effects from TAK-660.
- To check how well TAK-660 controls bleeding when used routinely during surgery and other invasive procedures such as tooth extractions.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
During the study, participants will receive infusions of TAK-660 during their hospital stay for surgery according to their clinic's standard practice. The study doctors will check for bleeds and side effects from TAK-660 from surgery until discharge.
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
- •Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.
排除标准
- 未提供
研究组 & 干预措施
TAK-660 15-50 international units per kilograms (IU/kg)
Participants will receive TAK-660 15-50 IU/kg slow intravenous injection every 8- 24 hours until the bleeding is resolved or wound healing.
干预措施: PEGylated Recombinant Factor VIII (Biological)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Up to 30 Days
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Number of Participants With Serious Adverse Events
时间窗: Up to 30 Days
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Number of Participants With Adverse Drug Reaction
时间窗: Up to 30 Days
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers to AE related to administered drug.
Number of Participants With Serious Adverse Drug Reaction
时间窗: Up to 30 Days
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse drug reaction refers to AE related to administered drug.
Number of Participants With Adverse Reactions Categorized as Inhibitor Development, Shock, or Anaphylaxis
时间窗: Up to 30 Days
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Number of participants with adverse reactions categorized as inhibitor development, shock, or anaphylaxis was reported.
次要结局
- Intraoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion(Day 1 (date of surgery))
- Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion 1 Day After Surgery(1 Day post-surgery)
- Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion at Completion of Perioperative Management(At completion of perioperative management (approximately 30 days after surgery))