A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus (CMV). Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post Authorization Study to Monitor Efficacy, Effectiveness, and Safety of Maribavir (LIVTENCITY®) in Patients With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
Overview
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.
Interventions
- Other No Intervention
This is non-interventional study.
Primary outcome measures
- Number of Participants With Adverse Events (AEs) [Time frame: From start of treatment up to Week 16]
Secondary outcome measures (3)
- Percentage of Participants Who Achieved Clearance of Plasma Cytomegalovirus -Deoxyribonucleic Acid (CMV-DNA) (CMV Viremia Clearance) at End of Weeks 8 and 16 [Time frame: At Weeks 8 and 16]
- Percentage of Participants Who Achieved CMV Infection Symptom Control at End of Weeks 8 and 16 [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 [Time frame: Up to Week 8]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
\- There are no specific exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Argentina · 1 center
- IC Projects — City of Buenos Aires
Identifiers
NCT: NCT06213974 · TAK-620-4008