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

Last updated: April 25, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cytomegalovirus Infections

Treatment

No Intervention

Clinical Study ID

NCT06615921
TAK-620-5010
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Aged greater than or equal to (>=) 18 years at the time of consent or start of chartabstraction 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 timeof Central Ethics Committee [CEC]/Local Ethics Committee [LEC] submission as perlocal regulation).

  • Participants with hospital medical chart available, who signed an informed consentform before starting any study procedures (unless waiver is allowed as per localregulation).

Exclusion

Exclusion criteria:

  • Participants who do not provide informed consent, where consent is required percountry regulations.

  • Participants who participated to Clinical Trials investigating maribavir.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
October 14, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Medical University of Vienna Dept. of Nephrology and Dialysis

    Vienna, 1090
    Austria

    Active - Recruiting

  • Copenhagen University Hospital, Rigshospitalet

    Copenaghen, 2100
    Denmark

    Site Not Available

  • Groupe Hospitalier Pellegrin - CHU BORDEAUX

    Bordeaux, 33000
    France

    Site Not Available

  • Department of Nephrology, University Hospital of Dijon

    Dijon, 21000
    France

    Site Not Available

  • Hopital Claude Huriez CHRU Lille

    Lille, 59000
    France

    Site Not Available

  • CHU Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • CHU De Nice Hopital Pasteur 2

    Nice, 06000
    France

    Site Not Available

  • APHP, Sorbonne University, Pitie Salpetriere Hospital

    Paris, 75013
    France

    Site Not Available

  • Hopital Saint-Louis AP-HP Pitor

    Paris, 75010
    France

    Site Not Available

  • Necker-Enfants Malades Hospital

    Paris, 75015
    France

    Site Not Available

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67000
    France

    Site Not Available

  • Toulouse University Hospital - Hopital de Rangueil

    Toulouse, 31400
    France

    Site Not Available

  • Uniklinik RWTH Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Charite, Dept of Nephrology

    Berlin, 10117
    Germany

    Site Not Available

  • Clinic for Infectiology - Essen

    Essen, 45147
    Germany

    Site Not Available

  • University Hospital Greifswald

    Greifswald, 17475
    Germany

    Site Not Available

  • Clinic for stem cell transplantation - Hamburg (UKE)

    Hamburg, 20246
    Germany

    Site Not Available

  • Hannover Medical School - Resp Medicine

    Hannover, 30625
    Germany

    Site Not Available

  • Uniklinik Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Medicine Clinic of Johannes Gutenberg - Mainz university

    Mainz, 55131
    Germany

    Site Not Available

  • Ludwig-Maximilians University (LMU) Hospital

    Munich, 80336
    Germany

    Site Not Available

  • University of Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Wurzburg, 97080
    Germany

    Site Not Available

  • Policlinico Gemelli - Roma

    Roma, 00136
    Italy

    Site Not Available

  • Erasmus MC Cancer Institute

    Rotterdam, 3015
    Netherlands

    Site Not Available

  • UMC Utrecht (Hematology)

    Utrecht, 3584
    Netherlands

    Site Not Available

  • University of Belgrade

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center of Vojvodina

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de Cruces

    Bilbao, 48903
    Spain

    Site Not Available

  • Hospital Virgen de las Nieves

    Granada, 18014
    Spain

    Site Not Available

  • Hospital Dr. Negrin

    Las Palmas, 35010
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Puerta del Hierro

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • University Hospital of Geneva

    Geneva, 1205
    Switzerland

    Site Not Available

  • University Hospitals Birmingham

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Royal Papworth Hospital (Cambridge)

    Cambridge, CB2 0AY
    United Kingdom

    Site Not Available

  • Kings College Hospital (London)

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital (London)

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • University College Hospital London

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Freeman Hospital Newcastle upon Tyne

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

  • Nottingham University Hospital NHS trust (Queens Medical Centre)

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS FT

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

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