Letermovir for CMV Prevention After Lung Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

December 6, 2021

Primary Completion Date

March 3, 2025

Study Completion Date

March 3, 2025

Conditions
Lung TransplantCMV
Interventions
DRUG

Letermovir

Participants who are CMV R+ will receive LET prophylaxis for 6 months, and participants who are CMV D+/R- will receive LET prophylaxis for 12 months. The duration of prophylaxis is per current standard of care. LET will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If LET is co-administered with cyclosporin A (CsA), the dosage of LET should be decreased to 240 mg once daily. All patients will be followed for 12 weeks after completion of LET for the occurrence of CMV infection or disease after prophylaxis. Participants on this protocol will receive acyclovir 400 mg orally BID for the duration of LET therapy for herpes simplex virus and varicella zoster virus prophylaxis.

DRUG

Valganciclovir

Historical controls will have received CMV prophylaxis with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-.

Trial Locations (1)

15213

UPMC, Pittsburgh

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Fernanda P Silveira, MD, MS

OTHER

NCT05041426 - Letermovir for CMV Prevention After Lung Transplantation | Biotech Hunter | Biotech Hunter