Cytomegalovirus (CMV)
Conditions
Keywords
Drug Therapy
Brief summary
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
DRUGMaribavir
Maribavir tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs) | Up to 27 weeks | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers (ADR) to AE related to administered drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Confirmed CMV viremia Clearance | 27 weeks | Confirmed CMV viremia clearance will be assessed based on plasma CMV DNA concentration in plasma or CMV positive antigen cell in blood. |
| Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator | 27 weeks | Percentage of participants who have a response to CMV, as assessed by the investigator will be reported. |
| Percentage of Participants With Resistance to Maribavir Treatment | 27 weeks | Based on treatment and observation in clinical practice, incidence of CMV resistance to this drug is evaluated. |
| Percentage of Participants With Graft Rejection | 27 weeks | Percentage of participants With TEAEs of graft rejection will be reported. |
| Percentage of Participants With Graft-versus-host Disease (GVHD) | 27 weeks | Percentage of participants with TEAEs of GVHD will be reported. |
| Percentage of Participants With All-cause Mortality by the End of the Study | 27 weeks | Percentage of participants who died during the entire study period will be reported. |
Countries
Japan
Contacts
Primary ContactTakeda Contact
Outcome results
None listed