Clinical trial NCT06555432: A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Official title: Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytomegalovirus (CMV)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 168
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, foscarnet or cidofovir and initiate maribavir treatment for the first time will be enrolled.

Brief 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 criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
timeFrame: Up to Week 20
measure: Number of Participants With Expected/Unexpected AEs and SAEs
timeFrame: Up to Week 20
measure: Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Expected ADRs, Serious ADRs (SADRs) Expected SADRs and Unexpected SADRs
timeFrame: Up to Week 20
measure: Number of Participants With Special Situation Report (SSR)
timeFrame: Up to Week 20
Secondary outcomes:
measure: Percentage of Participants With CMV Viremia Clearance as Assessed by Polymerase Chain Reaction (PCR)
timeFrame: At Weeks 2, 8 and the last dose (up to 20 weeks)
measure: Percentage of Participants Who Achieved CMV Infection Symptom Control
timeFrame: At Weeks 2, 8 and the last dose (up to 20 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: