Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06677892

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cytomegalovirus (CMV)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Erasme, Anderlecht, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is non-interventional study.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. Number of Participants With Use of Maribavir in Daily Clinical Practice

    Time frame: Up to 16 weeks

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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)

Acronym: MARIBEL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.