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Prospective, Non-interventional Study to Describe the Use and Effectiveness of Maribavir in Adults With Post-transplant Cytomegalovirus Infection in Line With Belgian Reimbursement Conditions
Led by Takeda · Updated on 2025-09-09
75
Participants Needed
9
Research Sites
4 weeks
Total Duration
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AI-Summary
What this Trial Is About
Cytomegalovirus (CMV) is a common virus that can cause serious illness in people with weakened immune systems, especially those who have undergone transplants. Researchers are evaluating the use of maribavir, a medicine approved for treating CMV infection in adults after transplant, to learn how safe and effective it is in adults with post-transplant CMV infection in Belgium according to Belgian reimbursement rules. This is a non-interventional observational study where participants with post-transplant CMV infection or disease, who are starting maribavir treatment for the first time in line with Belgian reimbursement criteria, will be observed. The study collects data prospectively for up to 2 years without fixed hospital visits, relying mainly on routine visits and contacts. Participants will have their medical and treatment data collected during routine care visits over 2 years. Researchers will monitor outcomes such as how many participants clear the CMV virus, treatment duration, time to viral clearance, drug resistance, recurrence after treatment, and any treatment-related adverse events. The study aims to reflect real-world use of maribavir in daily clinical practice.
CONDITIONS
Brief Title
A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant signed an informed consent form.
- Aged 18 years or older at the time of consent.
- Received a hematopoietic stem-cell transplant (HSCT) or solid organ transplant (SOT).
- Diagnosed with CMV infection or disease any time after the transplant.
- Starting maribavir for the first time according to Belgian reimbursement criteria.
You will not qualify if you...
- Participant treated with maribavir before the start of the study.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants who are treated with maribavir for post-transplant CMV infection are observed to describe the use and effectiveness of the treatment in daily clinical practice.
Visits occur as part of routine clinical care over the observation period
Trial Site Locations
Total: 9 locations
1
Hôpital Erasme
Anderlecht, Belgium, 1070
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2
Institut Jules Bordet
Anderlecht, Belgium, 1070
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3
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
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4
UZA
Edegem, Belgium, 2640
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5
UZGent
Ghent, Belgium, 9000
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6
UZBrussel
Jette, Belgium, 1090
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7
UZLeuven
Leuven, Belgium, 3000
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8
CHU de Liège - site Sart Tilman
Liège, Belgium, 4000
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9
CHU UCL Namur - site Godinne
Yvoir, Belgium, 5530
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Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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