General Use-results Survey of OBIZUR for I.V. Injection (All-case Surveillance)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 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 a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). 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.
The main aim of the study is to check for side effects related from Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.
During the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).
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 participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).
排除标准
- 未提供
研究组 & 干预措施
Susoctocog Alfa (Genetical Recombination)
Participants will receive Susoctocog Alfa (Genetical Recombination) intravenous injection.
干预措施: Susoctocog Alfa (Genetical Recombination) (Drug)
结局指标
主要结局
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
时间窗: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
时间窗: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
- Number of Participants for Categories of Treatment Effectiveness with Susoctocog Alfa (Genetical Recombination) as Assessed by the Investigator(24 hours after the first dose of study drug, and the last dose for bleeding episode or discontinuation of study drug, whichever came first (varied from participant to participant))
- Number of Participants with Each Score of Eastern Cooperative Oncology Group (ECOG) Performance Status(Pre-dose, at the last dose or discontinuation of study drug, whichever came first, and 90 days after the last dose or discontinuation of study drug, whichever came first (varied from participant to participant))