Post Authorization Study to Monitor Efficacy, Effectiveness, and Safety of Maribavir (LIVTENCITY®) in Patients With Post-transplant Cytomegalovirus (CMV) Infection in Argentina

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Argentina
IC Projects
RECRUITING
City Of Buenos Aires
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2024-09-03
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 10
Treatments
All Participants
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.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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