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

September 2, 2025 updated by: Takeda

Prospective, Non-interventional Study to Describe The Use of Maribavir and Its Effectiveness in Patients With Post-transplant Cytomegalovirus Infection/Disease in Line With Belgian Reimbursement Conditions (The MARIBEL Study)

Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. Maribavir is a medicine approved for treating CMV infection in adults after transplant.

The main aim of this study is to check the use of maribavir and learn how safe and effective in treating adults with CMV infection after transplant in Belgium in line with the Belgian reimbursement criteria.

During the study, a participant's data will be collected for 2 years. The study does not have fixed visits to the hospital, but it is recommended collect data from routine visits and contacts.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Hôpital Erasme
        • Contact:
          • Site Contact
          • Phone Number: +32 (0) 555 33 34
        • Principal Investigator:
          • Kemlin, Dr.
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Principal Investigator:
          • Xavier Poiré, Prof. Dr.
        • Contact:
      • Edegem, Belgium, 2640
        • Recruiting
        • UZA
        • Contact:
        • Principal Investigator:
          • Anke Verlinden, Dr.
      • Ghent, Belgium, 9000
      • Jette, Belgium, 1090
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège - site Sart Tilman
        • Contact:
        • Principal Investigator:
          • Willems, Prof. Dr.
        • Principal Investigator:
          • Antoine Bouquegneau, Prof. Dr.
      • Yvoir, Belgium, 5530
        • Recruiting
        • CHU UCL Namur - Site Godinne
        • Contact:
          • Site Contact
          • Phone Number: +32 81 42 38 74
        • Principal Investigator:
          • Planté-Bordeneuve, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who had a CMV infection/disease after SOT/HSCT and who start maribavir, according to summary of product characteristics (SmPC) and in line with Belgian reimbursement criteria for maribavir will be included.

Description

Inclusion Criteria:

  • Participant signed an informed consent form.
  • Aged greater than or equal to (>=) 18 years at the time of consent.
  • Received an HSCT/SOT.
  • Diagnosed with CMV infection/disease any time after the HSCT/SOT date.
  • Starting maribavir for the first time and in line with the Belgian reimbursement criteria.

Exclusion Criteria:

• Participant treated with maribavir before the start of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants
Participants with post-transplant CMV infection and/or disease that are refractory or intolerant to one or more prior therapies, who have undergone a solid organ transplant/ hematopoietic stem-cell transplantation (SOT/HSCT) and are treated with maribavir for the first time and in line with the Belgian reimbursement criteria, data will be collected and observed prospectively for up to 2 years.
Other: No Intervention
This is non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Effectiveness of Maribavir on CMV Viremia Clearance
Time Frame: Up to 16 weeks
CMV viraemia clearance is defined as last CMV quantitative polymerase chain reaction (PCR) during maribavir treatment. Viral clearance plasma CMV DNA concentration below the lower limit of quantification (< LLOQ) less than [<] 137 international units per milliliters (IU/mL).
Up to 16 weeks
Duration of Treatment
Time Frame: From treatment start to discontinuation of maribavir (up to 16 weeks)
Duration of treatment is defined as time from treatment start to discontinuation of maribavir.
From treatment start to discontinuation of maribavir (up to 16 weeks)
Time to Viral Clearance
Time Frame: From treatment start to achievement of viral clearance (up to 2 years)
Time to viral clearance is defined as time from treatment start to achievement of viral clearance.
From treatment start to achievement of viral clearance (up to 2 years)
Number of Participants With Use of Maribavir in Daily Clinical Practice
Time Frame: Up to 16 weeks
Up to 16 weeks
Number of Participants Who Have Refractory CMV Infection With/Without Resistance, or Intolerance to a Previous CMV Treatment
Time Frame: Up to 16 weeks
Refractory CMV infection with resistance is defined as viral genetic alteration that decreases susceptibility to one or more antiviral drugs.
Up to 16 weeks
Percentage of Participants With Recurrence After Maribavir Treatment
Time Frame: Up to 2 years
Recurrence is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ in 2 consecutive plasma samples, after achieving confirmed viremia clearance. Viremia clearance will be defined as plasma CMV DNA concentration below the lower limit of quantification (< LLOQ) that is <137 IU/mL.
Up to 2 years
Number of Participants With Treatment Related Adverse Events (AEs)
Time Frame: Up to 2 years
The investigator is required to provide an assessment of the relationship of an AE to the studied drug(s), based on the consideration of all available information about the event, including temporal relationship to drug administration, recognized association with drug product/class, pharmacological plausibility, and alternative etiology (e.g., underlying illness, concurrent conditions, concomitant treatments). An related AE is defined as AE that follows a reasonable temporal sequence from administration of the medication, vaccine, or device (including the course after withdrawal of the medication), and for which a causal relationship is at least a reasonable possibility, i.e., the relationship cannot be ruled out, although factors other than the medication, vaccine, or device, such as underlying diseases, complications, concomitant drugs, and concurrent treatments, may also have contributed.
Up to 2 years
Percentage of Participants With Drug Resistance
Time Frame: Up to 2 years
Percentage of participants with drug resistance (UL97/UL27 genes) testing will be reported.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-620-4014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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