臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 09, 2026
Last modified on	April. 09, 2026
Trial ID	jRCT1031250785

Scientific Title	A Prospective Single-Center Exploratory Study of Letermovir for Cytomegalovirus Prophylaxis in Perioperative Liver Transplantation
Public Title	A Prospective Single-Center Exploratory Study of Letermovir for Cytomegalovirus Prophylaxis in Perioperative Liver Transplantation

Contact for Scientific Queries	Name	Hasegawa Kiyoshi
	Affiliation	The University of Tokyo Hospital
	Address	7-3-1 Hongo, Bunkyo-ku,Tokyo
	Telephone	+81-3-3815-5411
	E-mail	hasegawa-2su@h.u-tokyo.ac.jp
Contact for Public Queries	Name	Saruta Yuya
	Affiliation	The University of Tokyo Hospital
	Address	7-3-1 Hongo. Bunkyo-ku
	Telephone	+81-3-3815-5411
	E-mail	tsukubamd39@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 09, 2026
Actual date of first enrollment		April. 01, 2026
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion 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	(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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cytomegalovirus(CMV) infection
Intervention(s)		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 7 and 10.
Health Condition(s) Keyword		CMV
Intervention(s) Keyword		Letermovir(Prevymis)
Primary Outcome(s)		CMV positivity rate within 90 days after liver transplantation.
Secondary Outcome(s)		(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.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Te University of Tokyo, Clinical Reserch Review Board
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Tokyo
Telephone	+81-3-5841-3600
E-Mail	mgr-ohrs@m.u-tokyo.ac.jp
Approval Status	Approval
Date of approval	Feb. 03, 2026

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 09, 2026	(this page)	Changes
1	Mar. 09, 2026	Detail

List of change history