Actively Recruiting
Post-Marketing Surveillance of LIVTENCITY Tablet (Maribavir) for Cytomegalovirus Infection After Transplantation in South Korea
Led by Takeda · Updated on 2025-11-18
168
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Cytomegalovirus (CMV) is a common virus that can cause serious illness, especially in people with weakened immune systems after a transplant. Researchers are evaluating the safety and effectiveness of LIVTENCITY (Maribavir), a medicine approved in South Korea for treating CMV infection in adults after transplantation. This observational study aims to learn how LIVTENCITY works in routine clinical practice for these patients. Participants who have CMV infection or disease after a transplant and are resistant or refractory to one or more prior therapies such as ganciclovir, valganciclovir, foscarnet, or cidofovir will be treated with LIVTENCITY tablets as decided by their doctors. The study will follow participants for up to 20 weeks while they receive treatment according to approved labeling. During this approximately 5-month period, participant information will be collected without fixed hospital visit requirements, though visiting the study doctor about six times is recommended. Researchers will monitor adverse events, drug reactions, and CMV viral clearance through PCR tests at weeks 2, 8, and the end of treatment. They will also assess symptom control and collect safety data throughout the study.
CONDITIONS
Brief Title
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with post-transplant CMV infection or disease who are refractory or resistant to one or more prior therapies including ganciclovir, valganciclovir, cidofovir, or foscarnet
- Participants aged 19 years or older
- Participants starting their first treatment course with maribavir
- Participants who voluntarily consent to participate in the study
You will not qualify if you...
- Participants for whom LIVTENCITY (maribavir) is contraindicated according to the product label
- Participants previously treated with maribavir in any study or as a marketed drug
- Participants currently enrolled in other clinical trials for post-transplant CMV infection or receiving other experimental treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 20 weeks
Participants receive LIVTENCITY tablet as per their physician's discretion in a routine clinical practice setting for post-transplant CMV infection.
Visits at Weeks 2, 8, and the last dose (up to 20 weeks)
Trial Site Locations
Total: 1 location
1
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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