A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection
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: Maribavir.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus (CMV). Basic parameters: No limits · 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
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)
Overview
This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation). The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection, and to check side effect from the study treatment. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants with CMV infection will take Maribavir tablets according to their clinic's standard practice. The study doctors will check for side effects from Maribavir tablets for 27 weeks.
Interventions
- Drug Maribavir
Maribavir tablets
Primary outcome measures
- Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs) [Time frame: Up to 27 weeks]
Secondary outcome measures (6)
- Percentage of Participants With Confirmed CMV viremia Clearance [Time frame: 27 weeks]
- Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator [Time frame: 27 weeks]
- Percentage of Participants With Resistance to Maribavir Treatment [Time frame: 27 weeks]
- Percentage of Participants With Graft Rejection [Time frame: 27 weeks]
- Percentage of Participants With Graft-versus-host Disease (GVHD) [Time frame: 27 weeks]
- Percentage of Participants With All-cause Mortality by the End of the Study [Time frame: 27 weeks]
Eligibility criteria
Inclusion criteria
\- All participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).
Exclusion criteria
\- None
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
Japan · 1 center
- Takeda selected site — Tokyo
Identifiers
NCT: NCT06577363 · TAK-620-4013 · jRCT2031240302