A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection
ConditionCytomegalovirus (CMV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTakeda
About this trial
This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).
The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection, and to check side effect from the study treatment. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
During the study, participants with CMV infection will take Maribavir tablets according to their clinic's standard practice. The study doctors will check for side effects from Maribavir tablets for 27 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The population of this survey are all participants who meet the inclusion/exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Maribavir
DrugMaribavir tablets
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Maribavir1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs)
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers (ADR) to AE related to administered drug.
Time frame
Up to 27 weeksSecondary outcomes
1
Percentage of Participants With Confirmed CMV viremia Clearance
Confirmed CMV viremia clearance will be assessed based on plasma CMV DNA concentration in plasma or CMV positive antigen cell in blood.
Time frame
27 weeks2
Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator
Percentage of participants who have a response to CMV, as assessed by the investigator will be reported.
Time frame
27 weeks3
Percentage of Participants With Resistance to Maribavir Treatment
Based on treatment and observation in clinical practice, incidence of CMV resistance to this drug is evaluated.
Time frame
27 weeks4
Percentage of Participants With Graft Rejection
Percentage of participants With TEAEs of graft rejection will be reported.
Time frame
27 weeks Source ClinicalTrials.gov