Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 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 Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).
The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection, and to check side effect from the study treatment. 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 with CMV infection will take Maribavir tablets according to their clinic's standard practice. The study doctors will check for side effects from Maribavir tablets for 27 weeks.
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 Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).
排除标准
- 未提供
研究组 & 干预措施
Maribavir
Maribavir 400 milligrams (mg), tablets, orally twice a day.
干预措施: Maribavir (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 27 weeks
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 (ADR) to AE related to administered drug.
次要结局
- Percentage of Participants With All-cause Mortality by the End of the Study(27 weeks)
- Percentage of Participants With Graft Rejection(27 weeks)
- Percentage of Participants With Confirmed CMV viremia Clearance(27 weeks)
- Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator(27 weeks)
- Percentage of Participants With Resistance to Maribavir Treatment(27 weeks)
- Percentage of Participants With Graft-versus-host Disease (GVHD)(27 weeks)