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

Last updated: November 18, 2024
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cytomegalovirus Infections

Treatment

LIVTENCITY

Clinical Study ID

NCT06555432
TAK-620-4002
  • Ages > 19
  • All Genders

Study 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

Inclusion Criteria:

  • Participants with post-transplant CMV infection and/or disease who are refractoryand/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

Exclusion Criteria:

  • Participants for whom LIVTENCITY Tablet (maribavir) is contraindicated as perproduct label.

  • Participants previously treated with maribavir in any study or as marketed drug.

  • Participants actively participating in other clinical trials of post-transplant CMVinfection treatment or with other experimental treatments.

Study Design

Total Participants: 168
Treatment Group(s): 1
Primary Treatment: LIVTENCITY
Phase:
Study Start date:
November 14, 2024
Estimated Completion Date:
October 01, 2028

Connect with a study center

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

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.