A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection
NCT ID: NCT06615921
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
265 participants
OBSERVATIONAL
2024-10-14
2025-07-04
Brief Summary
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Only data already available in the medical records of the participants will be reviewed and collected during this study.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No Intervention
This is a non-interventional study.
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.
No Intervention
This is a non-interventional study.
Interventions
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No Intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
* 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 participated to Clinical Trials investigating maribavir.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Medical University of Vienna Dept. of Nephrology and Dialysis
Vienna, , Austria
Copenhagen University Hospital, Rigshospitalet
Copenhagen, , 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
Hanover, , 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
Würzburg, , 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 Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de Cruces
Bilbao, , 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
Countries
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Related Links
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To obtain more information about this study, click this link.
Other Identifiers
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TAK-620-5010
Identifier Type: -
Identifier Source: org_study_id
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