Actively Recruiting
Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)
Led by Takeda · Updated on 2025-10-07
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Maribavir tablets in people with Cytomegalovirus (CMV) infection that does not respond to existing anti-CMV treatments after organ transplantation, including stem cell transplants. The study aims to see if Maribavir can help protect Japanese patients from CMV infection and to monitor any side effects from this treatment. Participants will take Maribavir tablets at a dose of 400 milligrams twice daily, following their clinic's usual care practice. The study is observational, meaning the sponsor will provide guidance on recording treatment effects but will not control how clinics deliver the medication. During the 27-week study period, doctors will observe and record any side effects from Maribavir. They will also monitor outcomes such as clearance of CMV in the blood, response to treatment, resistance to the drug, graft rejection, graft-versus-host disease, and overall survival. Participants will be involved in regular monitoring and assessments throughout the study duration.
CONDITIONS
Brief Title
A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have Cytomegalovirus (CMV) infection that is resistant to existing anti-CMV therapy after organ transplantation, including hematopoietic stem cell transplantation.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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.
1 visit (in-person)
Duration - Up to 27 weeks
Participants receive Maribavir tablets orally twice a day for their cytomegalovirus infection.
Visits scheduled according to clinical needs during treatment
Duration - Up to 27 weeks
Participants are monitored for adverse drug reactions and treatment outcomes after completing Maribavir treatment.
Visits scheduled according to clinical needs during follow-up
Trial Site Locations
Total: 1 location
1
Takeda selected site
Tokyo, Japan
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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