Cytomegalovirus (CMV)
Conditions
Keywords
Drug Therapy
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo Intervention
This is a non-interventional study.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged greater than or equal to (\>=) 18 years at the time of consent or start of chart abstraction in case a consent waiver will be allowed as per local regulation. * Received an HSCT/SOT. * Diagnosed with CMV infection/disease any time after the HSCT/SOT date. * Initiated maribavir at least 4 months before the chart abstraction date (or at time of Central Ethics Committee \[CEC\]/Local Ethics Committee \[LEC\] submission as per local regulation). * Participants with hospital medical chart available, who signed an informed consent form before starting any study procedures (unless waiver is allowed as per local regulation).
Exclusion criteria
* Participants who do not provide informed consent, where consent is required per country regulations. * Participants who participated to Clinical Trials investigating maribavir.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Viremia Clearance Before 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of participants will be reported by transplant-related characteristics (type of transplant \[HSCT/SOT\]), transplant indication, donor and recipient CMV serostatus). |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | Number of repeated treatments with maribavir per CMV episode will be reported during index and/or post-index CMV episodes. |
| 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 | Number of participants who received maribavir, as derived from the treatments sequence within a specific CMV episode, stratified by line of therapy. |
| 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 | Number of participants with maribavir dose adjustments and average dose adjustments will be reported. |
| 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 | 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. |
| 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 | Number of participants categorized by their reasons for initiating and discontinuing maribavir treatment will be reported. |
| 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 | Number of participants categorized by place of initiation of maribavir treatment (Home/Hospital) will be reported. |
| 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 | Number of days of maribavir treatment during hospital in-patient stay will be reported. |
| 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 | 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. |
| 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 | Number of participants who received concomitant use of CMV-specific IgG during maribavir treatment will be reported. |
| 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 | Number of participants who received concomitant use of G-CSF during maribavir treatment will be reported. |
| 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 | Number of participants with immunosuppressive therapy adjustments during Index and/or Post-index CMV episodes will be reported. |
| 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 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 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 | 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. |
| 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 | Number of participants will be reported by their demographic characteristics (age, sex, past conditions and comorbidities). |
| 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 | 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. |
| 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 | Percentage of participants with tissue invasive disease during Index and/or Post-index CMV episodes will be reported. |
| 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 | Time to event of tissue invasive disease will be reported. |
| 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 | Percentage of participants with CMV syndrome disease will be reported. |
| 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 | Time to event of CMV syndrome disease will be reported. |
| 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 | Number of participants with reduction or resolution of CMV disease/syndrome at the end of maribavir treatment will be reported. |
| 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 | Time to reduction or resolution of CMV disease/syndrome after maribavir initiation will be reported. |
| 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 | Number of participants with asymptomatic and symptomatic recurrent CMV viremia (Post-index CMV episode) will be reported. |
| 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 | Time from maribavir discontinuation to next CMV treatment and anti-CMV agent will be reported. |
| 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 | Number of participants with detected anti-CMV resistance mutations prior to and after initiation of maribavir will be reported. |
| 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 | 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. |
| 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 | Number of participants with abnormal laboratory parameters related to AESI will be reported. Laboratory parameters refer to complete blood count, glomerular filtration, etc. |
| 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 | Number of participants with AESI related to the administration of maribavir will be reported. |
| 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 | 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. |
| 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 | Length of hospital stay in days for CMV -related hospitalizations will be reported. |
| 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 | Duration in days of stay in critical care and non-critical care will be reported. |
| 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 | 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. |
Countries
Austria, Denmark, France, Germany, Italy, Netherlands, Serbia, Spain, Switzerland, United Kingdom
Outcome results
None listed