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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With CMV Infection Refractory | 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. |
| |
| Participants With CMV Infection Intolerant | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Categorized Based on Demographic Characteristics | Number of participants will be reported by their demographic characteristics (age, sex, past conditions and comorbidities). | From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months |
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Inclusion criteria:
Exclusion criteria:
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Participants who have been diagnosed with Post-Transplant Cytomegalovirus infection/disease in several European countries.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna Dept. of Nephrology and Dialysis | Vienna | 1090 | Austria | |||
| Copenhagen University Hospital, Rigshospitalet |
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| Label | URL |
|---|---|
| To obtain more information about this study, click this link. | View source |
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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.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| 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). |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months |
| Copenhagen |
| 2100 |
| Denmark |
| Groupe Hospitalier Pellegrin - CHU BORDEAUX | Bordeaux | 33000 | France |
| Department of Nephrology, University Hospital of Dijon | Dijon | 21000 | France |
| Hopital Claude Huriez CHRU Lille | Lille | 59000 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| CHU De Nice Hopital Pasteur 2 | Nice | 06000 | France |
| Hopital Saint-Louis AP-HP Pitor | Paris | 75010 | France |
| APHP, Sorbonne University, Pitie Salpetriere Hospital | Paris | 75013 | France |
| Necker-Enfants Malades Hospital | Paris | 75015 | France |
| Hopitaux Universitaires de Strasbourg | Strasbourg | 67000 | France |
| Toulouse University Hospital - Hopital de Rangueil | Toulouse | 31400 | France |
| Uniklinik RWTH Aachen | Aachen | 52074 | Germany |
| Charite, Dept of Nephrology | Berlin | 10117 | Germany |
| Clinic for Infectiology - Essen | Essen | 45147 | Germany |
| University Hospital Greifswald | Greifswald | 17475 | Germany |
| Clinic for stem cell transplantation - Hamburg (UKE) | Hamburg | 20246 | Germany |
| Hannover Medical School - Resp Medicine | Hanover | 30625 | Germany |
| Uniklinik Leipzig | Leipzig | 04103 | Germany |
| Medicine Clinic of Johannes Gutenberg - Mainz university | Mainz | 55131 | Germany |
| Ludwig-Maximilians University (LMU) Hospital | Munich | 80336 | Germany |
| University of Ulm | Ulm | 89081 | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | 97080 | Germany |
| Policlinico Gemelli - Roma | Roma | 00136 | Italy |
| Erasmus MC Cancer Institute | Rotterdam | 3015 | Netherlands |
| UMC Utrecht (Hematology) | Utrecht | 3584 | Netherlands |
| University of Belgrade | Belgrade | 11000 | Serbia |
| Clinical Center of Vojvodina | Novi Sad | 21000 | Serbia |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de Cruces | Bilbao | 48903 | Spain |
| Hospital Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Dr. Negrin | Las Palmas | 35010 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Puerta del Hierro | Madrid | 28222 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| University Hospital of Geneva | Geneva | 1205 | Switzerland |
| University Hospitals Birmingham | Birmingham | B15 2GW | United Kingdom |
| Royal Papworth Hospital (Cambridge) | Cambridge | CB2 0AY | United Kingdom |
| University College Hospital London | London | NW1 2BU | United Kingdom |
| Kings College Hospital (London) | London | SE5 9RS | United Kingdom |
| Royal Marsden Hospital (London) | London | SW3 6JJ | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Freeman Hospital Newcastle upon Tyne | Newcastle | NE7 7DN | United Kingdom |
| Nottingham University Hospital NHS trust (Queens Medical Centre) | Nottingham | NG5 1PB | United Kingdom |
| University Hospital Southampton NHS FT | Southampton | SO16 6YD | United Kingdom |