An observational study in Cytomegalovirus (CMV), sponsored by Takeda. Completed at 45 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Takeda · Observational
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.
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.
Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who have been diagnosed with Post-Transplant Cytomegalovirus infection/disease in several European countries.
Exclusion criteria:
Participants who had a CMV infection/disease that is refractory to treatment (with or without resistance). Data will be retrospectively collected from date of solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT) up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Participants will be considered as refractory if they show no change or increased viremia after at least 2 weeks of appropriately dosed antiviral therapy.
Other: No Intervention
Participants with CMV infection intolerant to anti-CMV treatment. Data will be retrospectively collected from date of SOT/HSCT up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Intolerant participants identified based on physician judgment.
Other: No Intervention
This is a non-interventional study.
Number of Participants With Viremia Clearance Before the End of Maribavir Treatment
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.
Time frame: 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 Based on Demographic Characteristics
Number of participants will be reported by their demographic characteristics (age, sex, past conditions and comorbidities).
Time frame: 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
Number of participants will be reported by transplant-related characteristics (type of transplant \[HSCT/SOT\]), transplant indication, donor and recipient CMV serostatus).
Time frame: 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)
Number of participants with prior CMV infections and clinical manifestations of CMV disease before Index CMV episode. Index CMV episode is defined as first CMV episode treated with maribavir.
Time frame: 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
Number of participants will be reported by treatments used (e.g. valganciclovir, ganciclovir, cidofovir, foscarnet or letermovir), by number and sequence of treatments/per CMV episode, by treatment strategy (e.g. prophylaxis, pre-emptive, treatment) before Index CMV episode. Index CMV episode is defined as first CMV episode treated with maribavir.
Time frame: 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
Duration between start and end of treatment during Index and Post-index CMV episodes will be reported. Index CMV episode is defined as first CMV episode treated with maribavir. Post-index CMV episode is defined as first CMV recurrent episode after Index episode.
Time frame: 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
Number of repeated treatments with maribavir per CMV episode will be reported during index and/or post-index CMV episodes.
Time frame: 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
Number of participants who received maribavir, as derived from the treatments sequence within a specific CMV episode, stratified by line of therapy.
Time frame: 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
Number of participants with maribavir dose adjustments and average dose adjustments will be reported.
Time frame: 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
Available CMV viral loads of interest prior to maribavir initiation, during treatment with maribavir, and after discontinuation will be reported for each maribavir treatment administered.
Time frame: 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
Number of participants categorized by their reasons for initiating and discontinuing maribavir treatment will be reported.
Time frame: 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
Number of participants categorized by place of initiation of maribavir treatment (Home/Hospital) will be reported.
Time frame: 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
Number of days of maribavir treatment during hospital in-patient stay will be reported.
Time frame: 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
Number of participants who received maribavir as monotherapy or in combination with other antivirals such as valganciclovir, ganciclovir, letermovir, cidofovir or foscarnet will be reported.
Time frame: 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
Number of participants who received concomitant use of CMV-specific IgG during maribavir treatment will be reported.
Time frame: 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)
Number of participants who received concomitant use of G-CSF during maribavir treatment will be reported.
Time frame: 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
Number of participants with immunosuppressive therapy adjustments during Index and/or Post-index CMV episodes will be reported.
Time frame: 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
Time to first CMV viremia clearance (first negative PCR) after initiation of maribavir will be reported. CMV viremia clearance is defined as a negative Quantitative 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.
Time frame: 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
Time to first CMV viremia control after initiation of maribavir will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment.
Time frame: 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
Number of participants with CMV viremia control per week after initiation of maribavir will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment.
Time frame: 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
Number of participants with cumulative CMV viremia control at the end of maribavir treatment will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment.
Time frame: 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
Percentage of participants with tissue invasive disease during Index and/or Post-index CMV episodes will be reported.
Time frame: 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
Time to event of tissue invasive disease will be reported.
Time frame: 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
Percentage of participants with CMV syndrome disease will be reported.
Time frame: 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
Time to event of CMV syndrome disease will be reported.
Time frame: 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
Number of participants with reduction or resolution of CMV disease/syndrome at the end of maribavir treatment will be reported.
Time frame: 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
Time to reduction or resolution of CMV disease/syndrome after maribavir initiation will be reported.
Time frame: 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)
Number of participants with asymptomatic and symptomatic recurrent CMV viremia (Post-index CMV episode) will be reported.
Time frame: 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
Time from maribavir discontinuation to next CMV treatment and anti-CMV agent will be reported.
Time frame: 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
Number of participants with detected anti-CMV resistance mutations prior to and after initiation of maribavir will be reported.
Time frame: 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)
Number of participants with Anti-CMV Treatment Related AESI will be reported. AESI will include myelosuppression (for example, leucopenia, thrombocytopenia, lymphopenia, neutropenia, etc.), nephrotoxicity and taste disturbances.
Time frame: 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
Number of participants with abnormal laboratory parameters related to AESI will be reported. Laboratory parameters refer to complete blood count, glomerular filtration, etc.
Time frame: 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
Number of participants with AESI related to the administration of maribavir will be reported.
Time frame: 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
Number of participants with outpatient visit/hospitalization related to CMV management will be reported. Participants will be categorized by type of visit (outpatient, hospitalizations/emergency department visits), primary reason for the visit, CMV-related exams/procedures.
Time frame: 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
Length of hospital stay in days for CMV -related hospitalizations will be reported.
Time frame: 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
Duration in days of stay in critical care and non-critical care will be reported.
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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