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

NCT ID: NCT06555432

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-14

Study Completion Date

2028-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus (CMV)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

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) will be treated with LIVTENCITY tablet as per treating physician's discretion in a routine clinical practice setting, according to the approved labelling and will be observed prospectively for up to a 20-week period.

LIVTENCITY

Intervention Type DRUG

LIVTENCITY tablet.

Interventions

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LIVTENCITY

LIVTENCITY tablet.

Intervention Type DRUG

Other Intervention Names

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Maribavir

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Takeda Contact

Role: CONTACT

+1-877-825-3327

Facility Contacts

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Site Contact

Role: primary

Related Links

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https://clinicaltrials.takeda.com/study-detail/8b425af2ffa2462a??page=1&idFilter=TAK-620-4002

To obtain more information on the study, click here/on this link

Other Identifiers

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TAK-620-4002

Identifier Type: -

Identifier Source: org_study_id

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