A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LIVTENCITY.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus (CMV). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
Overview
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.
Interventions
- Drug LIVTENCITY
LIVTENCITY tablet.
Primary outcome measures
- Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI) [Time frame: Up to Week 20]
- Number of Participants With Expected/Unexpected AEs and SAEs [Time frame: Up to Week 20]
- Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Expected ADRs, Serious ADRs (SADRs) Expected SADRs and Unexpected SADRs [Time frame: Up to Week 20]
- Number of Participants With Special Situation Report (SSR) [Time frame: Up to Week 20]
Secondary outcome measures (2)
- Percentage of Participants With CMV Viremia Clearance as Assessed by Polymerase Chain Reaction (PCR) [Time frame: At Weeks 2, 8 and the last dose (up to 20 weeks)]
- Percentage of Participants Who Achieved CMV Infection Symptom Control [Time frame: At Weeks 2, 8 and the last dose (up to 20 weeks)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- The Catholic University of Korea, Seoul ST. Mary's Hospital — Seoul
Identifiers
NCT: NCT06555432 · TAK-620-4002