RecruitingNCT06555432

A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea

Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea


Sponsor

Takeda

Enrollment

168 participants

Start Date

Nov 14, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. LIVTENCITY (Maribavir) is a medicine approved for treating CMV infection in adults after transplant in South Korea. The main aim of this study is to learn how safe and effective LIVTENCITY (Maribavir) is in treating adults with CMV infection after transplant in a routine clinical practice setting. During the study, a participant's data will be collected for about 5 months (20 weeks). The study does not have fixed visits to the hospital, but it is recommended to visit the study doctor approximately 6 times during study.


Eligibility

Min Age: 19 Years

Inclusion Criteria4

  • Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, cidofovir or foscarnet.
  • Participants with age greater than or equal to (\>=) 19 years.
  • Initiate first treatment course with maribavir.
  • Voluntarily consent to participate in the study.

Exclusion Criteria3

  • Participants for whom LIVTENCITY Tablet (maribavir) is contraindicated as per product label.
  • Participants previously treated with maribavir in any study or as marketed drug.
  • Participants actively participating in other clinical trials of post-transplant CMV infection treatment or with other experimental treatments.

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Interventions

DRUGLIVTENCITY

LIVTENCITY tablet.


Locations(1)

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

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NCT06555432


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