Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
研究概览
简要总结
Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. LIVTENCITY (Maribavir) is a medicine approved for treating CMV infection in adults after transplant in South Korea.
The main aim of this study is to learn how safe and effective LIVTENCITY (Maribavir) is in treating adults with CMV infection after transplant in a routine clinical practice setting.
During the study, a participant's data will be collected for about 5 months (20 weeks). The study does not have fixed visits to the hospital, but it is recommended to visit the study doctor approximately 6 times during 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, cidofovir or foscarnet.
- •Participants with age greater than or equal to (>=) 19 years.
- •Initiate first treatment course with maribavir.
- •Voluntarily consent to participate in the study.
排除标准
- •Participants for whom LIVTENCITY Tablet (maribavir) is contraindicated as per product label.
- •Participants previously treated with maribavir in any study or as marketed drug.
- •Participants actively participating in other clinical trials of post-transplant CMV infection treatment or with other experimental treatments.
研究组 & 干预措施
All Participants
Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy (including ganciclovir, valganciclovir, foscarnet or cidofovir) will be treated with LIVTENCITY tablet as per treating physician's discretion in a routine clinical practice setting, according to the approved labelling and will be observed prospectively for up to a 20-week period.
干预措施: LIVTENCITY (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
时间窗: Up to Week 20
Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment.
Number of Participants With Expected/Unexpected AEs and SAEs
时间窗: Up to Week 20
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Expected ADRs, Serious ADRs (SADRs) Expected SADRs and Unexpected SADRs
时间窗: Up to Week 20
An ADR refers to a harmful and unintended reaction that occurs when an investigational product is normally administered or used, and when the causal relationship between the reaction and the investigational product cannot be ruled out. Among voluntarily reported AEs, if the causality between the AE and the investigational product is not known, it is considered an ADR. However, if both the reporter and the manufacturer/sponsor determine that the case is unrelated to the investigational product, it is excluded from being classified as an ADR. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome.
Number of Participants With Special Situation Report (SSR)
时间窗: Up to Week 20
SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use" for unintended benefit; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; AEs occurring in the pediatric or elderly population.
次要结局
- Percentage of Participants With CMV Viremia Clearance as Assessed by Polymerase Chain Reaction (PCR)(At Weeks 2, 8 and the last dose (up to 20 weeks))
- Percentage of Participants Who Achieved CMV Infection Symptom Control(At Weeks 2, 8 and the last dose (up to 20 weeks))