What is Maribavir studying for post-transplant cytomegalovirus infection?

Maribavir is being studied to learn about its safety and effectiveness in treating adults and children with post-transplant CMV infection in Argentina. Researchers are collecting data from routine medical practice to understand how Maribavir works in real-world settings. The study is sponsored by Takeda.

Who may be eligible for this post-transplant CMV infection clinical trial?

People aged 12 years and older with post-transplant CMV infection that is resistant to common treatments may be eligible. Participants must have received at least one dose of Maribavir and be able to provide informed consent or assent. The study is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this post-transplant CMV infection clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 12Years +

All Genders

ID06213974

Observational Study of Maribavir Treatment Safety and Effectiveness in Adults and Children 12 and Older With Post-transplant Cytomegalovirus Infection in Argentina

Led by Takeda · Updated on 2026-06-04

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 12Years +

All Genders

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.

Research Team

Takeda Contact

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