A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection
- Conditions
- Cytomegalovirus (CMV)
- Interventions
- Other: No Intervention
- Registration Number
- NCT06615921
- Lead Sponsor
- Takeda
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants With CMV Infection Refractory No Intervention 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 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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.
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.
Trial Locations
- Locations (45)
Medical University of Vienna Dept. of Nephrology and Dialysis
🇦🇹Vienna, Austria
Copenhagen University Hospital, Rigshospitalet
🇩🇰Copenaghen, Denmark
Groupe Hospitalier Pellegrin - CHU BORDEAUX
🇫🇷Bordeaux, France
Department of Nephrology, University Hospital of Dijon
🇫🇷Dijon, France
Hopital Claude Huriez CHRU Lille
🇫🇷Lille, France
CHU Montpellier
🇫🇷Montpellier, France
CHU De Nice Hopital Pasteur 2
🇫🇷Nice, France
Hopital Saint-Louis AP-HP Pitor
🇫🇷Paris, France
APHP, Sorbonne University, Pitie Salpetriere Hospital
🇫🇷Paris, France
Necker-Enfants Malades Hospital
🇫🇷Paris, France
Hopitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Toulouse University Hospital - Hopital de Rangueil
🇫🇷Toulouse, France
Uniklinik RWTH Aachen
🇩🇪Aachen, Germany
Charite, Dept of Nephrology
🇩🇪Berlin, Germany
Clinic for Infectiology - Essen
🇩🇪Essen, Germany
University Hospital Greifswald
🇩🇪Greifswald, Germany
Clinic for stem cell transplantation - Hamburg (UKE)
🇩🇪Hamburg, Germany
Hannover Medical School - Resp Medicine
🇩🇪Hannover, Germany
Uniklinik Leipzig
🇩🇪Leipzig, Germany
Medicine Clinic of Johannes Gutenberg - Mainz university
🇩🇪Mainz, Germany
Ludwig-Maximilians University (LMU) Hospital
🇩🇪Munich, Germany
University of Ulm
🇩🇪Ulm, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wurzburg, Germany
Policlinico Gemelli - Roma
🇮🇹Roma, Italy
Erasmus MC Cancer Institute
🇳🇱Rotterdam, Netherlands
UMC Utrecht (Hematology)
🇳🇱Utrecht, Netherlands
University of Belgrade
🇷🇸Belgrade, Serbia
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
Hospital de Cruces
🇪🇸Bilbao, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Dr. Negrin
🇪🇸Las Palmas, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Puerta del Hierro
🇪🇸Madrid, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
University Hospital of Geneva
🇨🇭Geneva, Switzerland
University Hospitals Birmingham
🇬🇧Birmingham, United Kingdom
Royal Papworth Hospital (Cambridge)
🇬🇧Cambridge, United Kingdom
University College Hospital London
🇬🇧London, United Kingdom
Kings College Hospital (London)
🇬🇧London, United Kingdom
Royal Marsden Hospital (London)
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Freeman Hospital Newcastle upon Tyne
🇬🇧Newcastle, United Kingdom
Nottingham University Hospital NHS trust (Queens Medical Centre)
🇬🇧Nottingham, United Kingdom
University Hospital Southampton NHS FT
🇬🇧Southampton, United Kingdom