A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
ConditionCytomegalovirus (CMV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorTakeda
About this trial
The main aim of this study is to learn about the safety of Maribavir in adults and children with post-transplant CMV infection in routine clinical practice in Argentina.
The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina.
Participants will be treated by their doctors according to normal medical practice. Study data will be collected either from information already available in the medical records or during study conduct.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult participants (18 years or older) and pediatric participants (12 years of age and older and weighing at least 35 kilogram [kg]) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet in the real-world setting of common clinical practice in Argentina.
Have received at least one dose of maribavir according to approved indications.
Have signed the mandatory informed consent/assent that has been agreed with national regulatory authorities (ANMAT) as applicable.
Disqualifiers
None
Trial population
Adult and pediatric participants with post-transplant CMV infection/disease that are refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet, that are treated with maribavir according to approved indications.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
No Intervention
Other interventionThis is non-interventional study.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. AEs will include both serious and non-serious AEs.
Time frame
From start of treatment up to Week 16Secondary outcomes
1
Percentage of Participants Who Achieved Clearance of Plasma Cytomegalovirus -Deoxyribonucleic Acid (CMV-DNA) (CMV Viremia Clearance) at End of Weeks 8 and 16
CMV viremia clearance will be defined as CMV DNA concentration below the lower limit of considered by each local site for clearance according to real-world clinical practice.
Time frame
At Weeks 8 and 162
Percentage of Participants Who Achieved CMV Infection Symptom Control at End of Weeks 8 and 16
CMV infection symptom control will be defined as resolution or improvement CMV disease/syndrome for participants symptomatic at baseline, or absence of the development of CMV disease/syndrome or participants asymptomatic at baseline.
Time frame
At Weeks 8 and 163
Percentage of Participants Who Achieved a Clinically Relevant Response Regardless of Whether Treatment was Discontinued Before 8 weeks of Therapy
Clinically relevant response will be defined as no need for the use of an antiviral at a therapeutic dose for at least 4 weeks after completing treatment with maribavir, due to clinical improvement (improvement of CMV-related symptoms or the absence of these in the case of asymptomatic infections) and virological improvement (decrease of at least 1 log of viremia during treatment with maribavir).
Time frame
Up to Week 8Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
IC ProjectsRecruitingC11119ACN, City of Buenos Aires
Argentina
Argentina Source ClinicalTrials.gov