An observational study in Cytomegalovirus (CMV), sponsored by Takeda. Completed at 1 site in Argentina. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Takeda · Observational
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.
Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria
- There are no specific exclusion criteria.
Participants who have received maribavir treatment for the approved indication after marketing authorization (de novo participants) and before marketing authorization (legacy participants) under expanded access type of program or compassionate use in the real-world setting. Data will be collected prospectively and/or retrospectively from the medical records during this observational period of 16 weeks.
Other: No Intervention
This is non-interventional study.
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 16
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 16
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 16
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 8
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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