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

NCT ID: NCT06677892

Last Updated: 2025-09-09

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

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-24

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus (CMV)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

This is non-interventional study.

Interventions

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No Intervention

This is non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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.
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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Hôpital Erasme

Anderlecht, , Belgium

Site Status RECRUITING

Institut Jules Bordet

Anderlecht, , Belgium

Site Status RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

UZA

Edegem, , Belgium

Site Status RECRUITING

UZGent

Ghent, , Belgium

Site Status RECRUITING

UZBrussel

Jette, , Belgium

Site Status RECRUITING

UZLeuven

Leuven, , Belgium

Site Status RECRUITING

CHU de Liège - site Sart Tilman

Liège, , Belgium

Site Status RECRUITING

CHU UCL Namur - site Godinne

Yvoir, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Takeda Contact

Role: CONTACT

+1-877-825-3327

Facility Contacts

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Site Contact

Role: primary

+32 (0) 555 33 34

Site Contact

Role: primary

Site Contact

Role: primary

02 764 18 55

Site Contact

Role: primary

Site Contact

Role: primary

Site Contact

Role: primary

Site Contact

Role: primary

Site Contact

Role: primary

04/323.37.92

Site Contact

Role: primary

+32 81 42 38 74

Related Links

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https://clinicaltrials.takeda.com/study-detail/8db9463ef5b74455??page=1&idFilter=TAK-620-4014

To obtain more information on the study, click here/on this link

Other Identifiers

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TAK-620-4014

Identifier Type: -

Identifier Source: org_study_id

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