Cytomegalovirus(CMV) infection CMV
Conditions
Interventions
For patients undergoing liver transplantation with high or intermediate CMV infection risk, letermovir(Prevymis) 480 mg will be administered once daily for 90 days, starting between postoperative day
Letermovir(Prevymis)
Sponsors
Hasegawa Kiyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) No history of CMV treatment. (2) Scheduled to undergo liver transplantation (brain-dead or living donor). (3) Patients at intermediate or high risk for CMV infection. (4) Age: 18 years or older at the time of obtaining consent. (5) Gender: Any. (6) Patients who have received a full explanation regarding participation in this study, fully understood the contents, and provided written informed consent of their own free will (or via a legally acceptable representative). (7) Patients capable of outpatient visits according to the study schedule.
Exclusion criteria
Exclusion criteria: (1) History of severe drug allergies such as anaphylactic shock or history of severe side effects. (2) Patients using concomitant drugs contraindicated in the package insert of Prevymis (pimozide, ergotamine tartrate/anhydrous caffeine/isopropylantipyrine, dihydroergotamine, methylergometrine, ergometrine). (3) Any other patients deemed unsuitable for participation in this study by the Principal Investigator or Sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CMV positivity rate within 90 days after liver transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) CMV positivity rate within 180 days after liver transplantation. (2) Incidence of CMV syndrome within 90 days and 180 days after liver transplantation. (3) Incidence of CMV infection accompanied by end-organ disease (tissue-invasive CMV disease) within 90 days and 180 days after liver transplantation. (4) Frequency of adverse events within 90 days and 180 days after liver transplantation. | — |
Contacts
Public ContactYuya Saruta
The University of Tokyo Hospital
Outcome results
None listed