Letermovir for CMV Prevention After Lung Transplantation

Last updated: July 2, 2025
Sponsor: Fernanda P Silveira, MD, MS
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

Letermovir

Valganciclovir

Clinical Study ID

NCT05041426
STUDY21040074
  • Ages 18-100
  • All Genders

Study Summary

This is an interventional, open-label, single center, pilot study with historical controls to test the efficacy of letermovir (LET) for the prevention of CMV infection and disease in adult lung transplant recipients (LTRs) with idiopathic pulmonary fibrosis (IPF).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years on day of signing informed consent

  • Listed for lung transplantation (single or double) due to a diagnosis of IPF orreceipt of a lung transplant (single or double) for IPF in the 72 hours prior toenrollment

  • Have a documented positive serostatus for CMV (CMV IgG seropositive, R+)

  • Have a documented negative serostatus for CMV (CMV IgG seronegative, R-) andanticipate receiving or having received a lung allograft from a CMV IgG positivedonor, D+). Only participants who are R+ or who are CMV D+/R- will receiveintervention. Participants who are CMV D-/R- will be considered screen failures

  • Able to travel to UPMC for routine post-transplant visits for a minimum of 15 monthsafter transplantation

  • Able to provide informed consent

  • Be willing to use a contraceptive method while receiving LET and for at least 90days following last dose of LET

Exclusion

Exclusion Criteria:

  • Receipt of a previous solid organ transplant or hematopoietic stem cell transplant

  • Multi-organ transplant recipient, i.e., heart-lung or lung-liver

  • HIV seropositive

  • HCV antibody or HCV RNA positive

  • Donor HCV NAT positive

  • Anticipated need for use of ganciclovir, valganciclovir, foscarnet, or cidofovir atthe time of transplant

  • Known or suspected hypersensitivity to LET or acyclovir

  • CrCl < 10 ml/min or dialysis on day of transplant

  • Child-Pugh Class C severe hepatic insufficiency

  • Pregnancy or expected to conceive while on LET and through at least 90 daysfollowing cessation of LET

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: Letermovir
Phase: 2
Study Start date:
December 06, 2021
Estimated Completion Date:
March 03, 2025

Study Description

Approximately 30 patients with IPF listed for lung transplantation will be enrolled and 15 are expected to undergo lung transplantation during the study period and receive the intervention. Patients who are CMV seropositive will receive letermovir for 6 months, patients who are CMV seronegative and receive lungs from a CMV seropositive donor (CMV D+/R-) will receive letermovir for 12 months. All patients will be followed for 12 weeks after completion of letermovir for the occurrence of CMV infection or disease after prophylaxis.

Historical controls will be LTRs for IPF from 2010-2019 who are CMV R+ or CMV D+/R- (donor positive/recipient negative). CMV prophylaxis in the historical controls was with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-. Patients will be matched for CMV serostatus, induction immunosuppression, age, and telomere length.

Connect with a study center

  • UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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