NCT06615921已完成不适用
A Multi-country, Multi-center, Retrospective Chart Review to Describe the Use of Maribavir and Its Effectiveness in Patients With Post-Transplant Cytomegalovirus Infection/Disease
Takeda45 个研究点 分布在 10 个国家目标入组 265 人开始时间: 2024年10月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 45
- 主要终点
- Number of Participants With Viremia Clearance Before the End of Maribavir Treatment
研究概览
简要总结
The main aim of this study is to check how effective the treatment with Maribavir has been to remove the CMV viruses from the blood of an adult person with CMV infection after a transplant. Other aims are to learn more about how maribavir is used in normal clinical routine, study the profiles of adults treated with maribavir, and what other treatments have been given, and describe healthcare resources used for CMV management.
Only data already available in the medical records of the participants will be reviewed and collected during this study.
详细描述
This study will include two main periods of retrospective data collection from medical charts: the pre-index period and the post-index period. The index date is defined as the date of initiation of maribavir dosing, as documented in the medical records. The pre-index period covers the time from the transplant date to the index event, while the post-index period starts at the index event and ends at the date of chart abstraction, death, or loss to follow-up, whichever comes first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Viremia Clearance Before the End of Maribavir Treatment
时间窗: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
CMV viremia clearance is defined as a negative Quantitative Polymerase Chain Reaction (PCR) result. A PCR result is defined as negative if CMV DNA is undetectable or below the lower limit of quantification as per local laboratory practice. Number of participants with the last CMV quantitative negative PCR result before the end of maribavir treatment will be reported.
次要结局
- Participants Categorized Based on Demographic Characteristics(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants Categorized by Transplant-Related Characteristics(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants Characterized by Previous CMV Infection (Medical History)(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants Characterized by Use of Prior Anti-CMV Treatment Strategies(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Duration of Each Treatment With Maribavir During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Number of Repeated Treatments With Maribavir During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Maribavir Administration by Line of Therapy During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Maribavir Dose Adjustments During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- CMV Viral Load Prior to Maribavir Initiation, During Treatment With Maribavir, and After Discontinuation(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Reasons for Initiating and Discontinuing Maribavir Treatment During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Place of Initiation of Maribavir Treatment(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Duration of Maribavir Treatment During Hospital In-patient Stay(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants who Received Maribavir Monotherapy or Maribavir in Combination With Other Antivirals(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants who Received Concomitant Use of CMV-Specific IgG During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Concomitant Use of Granulocyte Colony-Stimulating Factor (G-CSF)(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Immunosuppressive Therapy Adjustments During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Time to First CMV Viremia Clearance After Initiation of Maribavir During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Time to First CMV Viremia Control After Initiation of Maribavir During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With CMV Viremia Control per Week After Initiation of Maribavir During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Cumulative CMV Viremia Control at the End of Maribavir Treatment During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Incidence of Tissue Invasive Disease During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Time to Tissue Invasive Disease During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Incidence of CMV Syndrome Disease During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Time to CMV Syndrome Disease During Index and/or Post-Index CMV Episodes(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Reduction or Resolution of CMV Disease/Syndrome at the End of Maribavir Treatment(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Time to Reduction or Resolution of CMV Disease/Syndrome After Maribavir Initiation(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Recurrent CMV Viremia (Post-Index CMV Episode)(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Time From Maribavir Discontinuation to Next CMV Treatment and Anti-CMV Agent Used(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Anti-CMV Detected Resistance Mutations in the Study Population(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Anti-CMV Treatment Related Adverse Events of Special Interest (AESI)(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Abnormal Laboratory Parameters Related to AESI(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With AESI Related to the Administration of Maribavir(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Participants With Outpatient Visit/Hospitalization Related to CMV Management(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Length of Hospital Stay in Days for CMV-related Hospitalizations(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
- Duration in Days of Critical Care against Non-critical Care(From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months)
研究者
研究点 (45)
Loading locations...
相似试验
已完成
不适用
Prospective Observational Epidemiologic Study of Maraviroc's SafetyHuman Immunodeficiency VirusNCT00665561ViiV Healthcare2,500
终止
不适用
Fc factOrs and Real-World hemophiliA Patient-ReporteD OutcomesHemophilia BHemophilia ANCT02392156Bioverativ Therapeutics Inc.3
已完成
不适用
A Multicountry, Multicentre, Non-interventional, Retrospective Study to Determine Real-world Treatment Patterns and Associated Outcomes After First Line Osimertinib in Patients With Advanced and Metastatic NSCLC EGFRm in the GCC RegionCarcinoma, Non-Small-Cell LungNCT06039683AstraZeneca54
已完成
不适用
An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 InfectionHIV InfectionsNCT01902615Hoffmann-La Roche58
已完成
3 期
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant RecipientsCytomegalovirus InfectionsNCT00411645Shire681