A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium
ConditionCytomegalovirus (CMV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionThis is non-interventional study.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
Number 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 weeks2
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)3
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)4
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 Source ClinicalTrials.gov