Actively Recruiting
Post Authorization Study to Monitor Efficacy, Effectiveness, and Safety of Maribavir (LIVTENCITY®) in Patients With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
Led by Takeda · Updated on 2026-06-04
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the safety and effectiveness of Maribavir in adults and children aged 12 and older who have post-transplant cytomegalovirus (CMV) infection in routine clinical practice in Argentina. The study collects real-world data from medical records and during the conduct of the study to evaluate how Maribavir is used and its impact in this patient group. Participants include those who have received Maribavir treatment either after its marketing authorization or before through expanded access or compassionate use programs. Data will be collected both prospectively and retrospectively over an observation period of 16 weeks to monitor treatment outcomes and safety. During the study, participants will be monitored for adverse events from the start of treatment up to week 16. Researchers will also measure the clearance of CMV DNA in plasma, symptom control of CMV infection, and clinically relevant responses to treatment at weeks 8 and 16. The study involves no intervention beyond standard care, and all data are gathered through routine clinical practice observations.
CONDITIONS
Brief Title
A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- There are no specific exclusion criteria.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants who have received maribavir treatment are observed in the real-world setting to monitor efficacy, effectiveness, and safety.
Data collected from medical records prospectively and/or retrospectively during the observational period
Trial Site Locations
Total: 1 location
1
IC Projects
City of Buenos Aires, Argentina, C11119ACN
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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