Prospective, Non-interventional Study to Describe The Use of Maribavir and Its Effectiveness in Patients With Post-transplant Cytomegalovirus Infection/Disease in Line With Belgian Reimbursement Conditions (The MARIBEL Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 9
- 主要终点
- Number of Participants With Effectiveness of Maribavir on CMV Viremia Clearance
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. Maribavir is a medicine approved for treating CMV infection in adults after transplant.
The main aim of this study is to check the use of maribavir and learn how safe and effective in treating adults with CMV infection after transplant in Belgium in line with the Belgian reimbursement criteria.
During the study, a participant's data will be collected for 2 years. The study does not have fixed visits to the hospital, but it is recommended collect data from routine visits and contacts.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant signed an informed consent form.
- •Aged greater than or equal to (>=) 18 years at the time of consent.
- •Received an HSCT/SOT.
- •Diagnosed with CMV infection/disease any time after the HSCT/SOT date.
- •Starting maribavir for the first time and in line with the Belgian reimbursement criteria.
排除标准
- •Participant treated with maribavir before the start of the study.
研究组 & 干预措施
All Participants
Participants with post-transplant CMV infection and/or disease that are refractory or intolerant to one or more prior therapies, who have undergone a solid organ transplant/ hematopoietic stem-cell transplantation (SOT/HSCT) and are treated with maribavir for the first time and in line with the Belgian reimbursement criteria, data will be collected and observed prospectively for up to 2 years.
干预措施: No Intervention (Other)
结局指标
主要结局
Number of Participants With Effectiveness of Maribavir on CMV Viremia Clearance
时间窗: Up to 16 weeks
CMV viraemia clearance is defined as last CMV quantitative polymerase chain reaction (PCR) during maribavir treatment. Viral clearance plasma CMV DNA concentration below the lower limit of quantification (\< LLOQ) less than \[\<\] 137 international units per milliliters (IU/mL).
Duration of Treatment
时间窗: From treatment start to discontinuation of maribavir (up to 16 weeks)
Duration of treatment is defined as time from treatment start to discontinuation of maribavir.
Time to Viral Clearance
时间窗: From treatment start to achievement of viral clearance (up to 2 years)
Time to viral clearance is defined as time from treatment start to achievement of viral clearance.
Percentage of Participants With Drug Resistance
时间窗: Up to 2 years
Percentage of participants with drug resistance (UL97/UL27 genes) testing will be reported.
Number of Participants With Use of Maribavir in Daily Clinical Practice
时间窗: Up to 16 weeks
Number of Participants Who Have Refractory CMV Infection With/Without Resistance, or Intolerance to a Previous CMV Treatment
时间窗: Up to 16 weeks
Refractory CMV infection with resistance is defined as viral genetic alteration that decreases susceptibility to one or more antiviral drugs.
Percentage of Participants With Recurrence After Maribavir Treatment
时间窗: Up to 2 years
Recurrence is defined as plasma CMV DNA concentration greater than or equal to (\>=) LLOQ in 2 consecutive plasma samples, after achieving confirmed viremia clearance. Viremia clearance will be defined as plasma CMV DNA concentration below the lower limit of quantification (\< LLOQ) that is \<137 IU/mL.
Number of Participants With Treatment Related Adverse Events (AEs)
时间窗: Up to 2 years
The investigator is required to provide an assessment of the relationship of an AE to the studied drug(s), based on the consideration of all available information about the event, including temporal relationship to drug administration, recognized association with drug product/class, pharmacological plausibility, and alternative etiology (e.g., underlying illness, concurrent conditions, concomitant treatments). An related AE is defined as AE that follows a reasonable temporal sequence from administration of the medication, vaccine, or device (including the course after withdrawal of the medication), and for which a causal relationship is at least a reasonable possibility, i.e., the relationship cannot be ruled out, although factors other than the medication, vaccine, or device, such as underlying diseases, complications, concomitant drugs, and concurrent treatments, may also have contributed.
次要结局
未报告次要终点