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

NCT06615921 | Completed

• 1 other identifier: TAK-620-5010
• Study Type: observational
• Target: 265
• Locations: 10 countries
• Sites: 45

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.

Conditions

Cytomegalovirus (CMV)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (35)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

Other: No Intervention

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.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

Participants With CMV Infection Intolerant; Participants With CMV Infection Refractory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have been diagnosed with Post-Transplant Cytomegalovirus infection/disease in several European countries.

You may qualify if:

• 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).

You may not qualify if:

• Participants who do not provide informed consent, where consent is required per country regulations.
• Participants who participated to Clinical Trials investigating maribavir.

Sponsors & Collaborators

• Takeda: lead

Study Sites (45)

Medical University of Vienna Dept. of Nephrology and Dialysis

Vienna, 1090, Austria

Location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Groupe Hospitalier Pellegrin - CHU BORDEAUX

Bordeaux, 33000, France

Location

Department of Nephrology, University Hospital of Dijon

Dijon, 21000, France

Location

Hopital Claude Huriez CHRU Lille

Lille, 59000, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU De Nice Hopital Pasteur 2

Nice, 06000, France

Location

Hopital Saint-Louis AP-HP Pitor

Paris, 75010, France

Location

APHP, Sorbonne University, Pitie Salpetriere Hospital

Paris, 75013, France

Location

Necker-Enfants Malades Hospital

Paris, 75015, France

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Toulouse University Hospital - Hopital de Rangueil

Toulouse, 31400, France

Location

Uniklinik RWTH Aachen

Aachen, 52074, Germany

Location

Charite, Dept of Nephrology

Berlin, 10117, Germany

Location

Clinic for Infectiology - Essen

Essen, 45147, Germany

Location

University Hospital Greifswald

Greifswald, 17475, Germany

Location

Clinic for stem cell transplantation - Hamburg (UKE)

Hamburg, 20246, Germany

Location

Hannover Medical School - Resp Medicine

Hanover, 30625, Germany

Location

Uniklinik Leipzig

Leipzig, 04103, Germany

Location

Medicine Clinic of Johannes Gutenberg - Mainz university

Mainz, 55131, Germany

Location

Ludwig-Maximilians University (LMU) Hospital

Munich, 80336, Germany

Location

University of Ulm

Ulm, 89081, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

Policlinico Gemelli - Roma

Roma, 00136, Italy

Location

Erasmus MC Cancer Institute

Rotterdam, 3015, Netherlands

Location

UMC Utrecht (Hematology)

Utrecht, 3584, Netherlands

Location

University of Belgrade

Belgrade, 11000, Serbia

Location

Clinical Center of Vojvodina

Novi Sad, 21000, Serbia

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de Cruces

Bilbao, 48903, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Dr. Negrin

Las Palmas, 35010, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Puerta del Hierro

Madrid, 28222, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

University Hospital of Geneva

Geneva, 1205, Switzerland

Location

University Hospitals Birmingham

Birmingham, B15 2GW, United Kingdom

Location

Royal Papworth Hospital (Cambridge)

Cambridge, CB2 0AY, United Kingdom

Location

University College Hospital London

London, NW1 2BU, United Kingdom

Location

Kings College Hospital (London)

London, SE5 9RS, United Kingdom

Location

Royal Marsden Hospital (London)

London, SW3 6JJ, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Freeman Hospital Newcastle upon Tyne

Newcastle, NE7 7DN, United Kingdom

Location

Nottingham University Hospital NHS trust (Queens Medical Centre)

Nottingham, NG5 1PB, United Kingdom

Location

University Hospital Southampton NHS FT

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• To obtain more information about this study, click this link.

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 27, 2024
• Study Start: October 14, 2024
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: 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.

Locations

AU (1); DK (1); NL (2); IT (1); DE (11); FR (10); ES (7); SE (2); GB (9); CH (1)