A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection

NCT ID: NCT06615921

Last Updated: 2025-08-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-14

Study Completion Date

2025-07-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cytomegalovirus (CMV)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Copenhagen University Hospital, Rigshospitalet

Copenhagen, , Denmark

Site Status

Groupe Hospitalier Pellegrin - CHU BORDEAUX

Bordeaux, , France

Site Status

Department of Nephrology, University Hospital of Dijon

Dijon, , France

Site Status

Hopital Claude Huriez CHRU Lille

Lille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU De Nice Hopital Pasteur 2

Nice, , France

Site Status

Hopital Saint-Louis AP-HP Pitor

Paris, , France

Site Status

APHP, Sorbonne University, Pitie Salpetriere Hospital

Paris, , France

Site Status

Necker-Enfants Malades Hospital

Paris, , France

Site Status

Hopitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Toulouse University Hospital - Hopital de Rangueil

Toulouse, , France

Site Status

Uniklinik RWTH Aachen

Aachen, , Germany

Site Status

Charite, Dept of Nephrology

Berlin, , Germany

Site Status

Clinic for Infectiology - Essen

Essen, , Germany

Site Status

University Hospital Greifswald

Greifswald, , Germany

Site Status

Clinic for stem cell transplantation - Hamburg (UKE)

Hamburg, , Germany

Site Status

Hannover Medical School - Resp Medicine

Hanover, , Germany

Site Status

Uniklinik Leipzig

Leipzig, , Germany

Site Status

Medicine Clinic of Johannes Gutenberg - Mainz university

Mainz, , Germany

Site Status

Ludwig-Maximilians University (LMU) Hospital

Munich, , Germany

Site Status

University of Ulm

Ulm, , Germany

Site Status

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status

Policlinico Gemelli - Roma

Roma, , Italy

Site Status

Erasmus MC Cancer Institute

Rotterdam, , Netherlands

Site Status

UMC Utrecht (Hematology)

Utrecht, , Netherlands

Site Status

University of Belgrade

Belgrade, , Serbia

Site Status

Clinical Center of Vojvodina

Novi Sad, , Serbia

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital de Cruces

Bilbao, , Spain

Site Status

Hospital Virgen de las Nieves

Granada, , Spain

Site Status

Hospital Dr. Negrin

Las Palmas, , Spain

Site Status

Hospital 12 de Octubre

Madrid, , Spain

Site Status

Hospital Puerta del Hierro

Madrid, , Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status

University Hospital of Geneva

Geneva, , Switzerland

Site Status

University Hospitals Birmingham

Birmingham, , United Kingdom

Site Status

Royal Papworth Hospital (Cambridge)

Cambridge, , United Kingdom

Site Status

University College Hospital London

London, , United Kingdom

Site Status

Kings College Hospital (London)

London, , United Kingdom

Site Status

Royal Marsden Hospital (London)

London, , United Kingdom

Site Status

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

Freeman Hospital Newcastle upon Tyne

Newcastle, , United Kingdom

Site Status

Nottingham University Hospital NHS trust (Queens Medical Centre)

Nottingham, , United Kingdom

Site Status

University Hospital Southampton NHS FT

Southampton, , United Kingdom

Site Status

Countries

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Austria Denmark France Germany Italy Netherlands Serbia Spain Switzerland United Kingdom

Related Links

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Other Identifiers

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TAK-620-5010

Identifier Type: -

Identifier Source: org_study_id

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