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 Type
OBSERVATIONAL
Enrollment
75
This is non-interventional study.
Hôpital Erasme
Anderlecht, Belgium
RECRUITINGInstitut Jules Bordet
Anderlecht, Belgium
RECRUITINGCliniques Universitaires Saint-Luc
Brussels, Belgium
RECRUITINGUZA
Edegem, Belgium
RECRUITINGUZGent
Ghent, Belgium
RECRUITINGUZBrussel
Jette, Belgium
RECRUITINGUZLeuven
Leuven, Belgium
RECRUITINGCHU de Liège - site Sart Tilman
Liège, Belgium
RECRUITINGCHU UCL Namur - site Godinne
Yvoir, Belgium
RECRUITINGNumber of Participants With Effectiveness of Maribavir on CMV Viremia Clearance
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).
Time frame: Up to 16 weeks
Duration of Treatment
Duration of treatment is defined as time from treatment start to discontinuation of maribavir.
Time frame: From treatment start to discontinuation of maribavir (up to 16 weeks)
Time to Viral Clearance
Time to viral clearance is defined as time from treatment start to achievement of viral clearance.
Time frame: From treatment start to achievement of viral clearance (up to 2 years)
Percentage of Participants With Drug Resistance
Percentage of participants with drug resistance (UL97/UL27 genes) testing will be reported.
Time frame: Up to 2 years
Number of Participants With Use of Maribavir in Daily Clinical Practice
Time frame: Up to 16 weeks
Number of Participants Who Have Refractory CMV Infection With/Without Resistance, or Intolerance to a Previous CMV Treatment
Refractory CMV infection with resistance is defined as viral genetic alteration that decreases susceptibility to one or more antiviral drugs.
Time frame: Up to 16 weeks
Percentage of Participants With Recurrence After Maribavir Treatment
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.
Time frame: Up to 2 years
Number of Participants With Treatment Related Adverse Events (AEs)
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.
Time frame: Up to 2 years
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