Evaluating Maribavir for CMV Infection in Post-Transplant Adults in Argentina
Post Authorization Study to Monitor Efficacy, Effectiveness, and Safety of Maribavir (LIVTENCITY®) in Patients With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
This study is testing if Maribavir can safely help adults in Argentina who have a tough-to-treat CMV infection after a transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (City of Buenos Aires) |
| Trial ID | NCT06213974 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of Maribavir in adults suffering from post-transplant cytomegalovirus (CMV) infection in Argentina. Participants will receive treatment as per standard medical practice, and data will be collected from existing medical records or during the study. The focus is on individuals whose CMV infection is refractory to conventional treatments. This observational approach allows for real-world insights into the drug's performance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with post-transplant CMV infection that has not responded to standard antiviral treatments.
Not a fit: Patients who do not have post-transplant CMV infection or those who have not received Maribavir are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of Maribavir, potentially improving treatment options for patients with resistant CMV infections.
How similar studies have performed: While this study focuses on a specific population and treatment, similar observational studies have shown promise in evaluating real-world treatment effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
City of Buenos Aires
- IC Projects — City of Buenos Aires, Argentina (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.