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NCT06066957

Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients

Recruiting now Phase 2 Last updated 21 May 2025
What this trial tests

Phase 2 trial testing Letermovir 480 MG [Prevymis] in Cytomegalovirus Infections in 80 participants. Currently enrolling.

Timeline
4 April 2024
Primary endpoint
15 August 2026
15 August 2026

Quick facts

Lead sponsorUniversity of Pennsylvania
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment80
Start date4 April 2024
Primary completion15 August 2026
Estimated completion15 August 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Cytomegalovirus Infections or Transplant-Related Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients. The study hypotheses are: 1. Letermovir prophylaxis will be associated with similar rates of CMV infection as valganciclovir among heart and lung transplant recipients 2. Letermovir will be better tolerated than valganciclovir for CMV prophylaxis in heart and lung transplant recipients, with a higher proportion of days of completed therapy with correct dosing during the planned prophylaxis period 3. Letermovir will have a lower rate of neutropenia than valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients 4. Incorrect renal dosing will occur less frequently with letermovir than with valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Management of Cytomegalovirus Infections in the Era of the Novel Antiviral Players, Letermovir and Maribavir.
    Piret J, Boivin G. · · 2024 · cited 14× · PMID 38247977 · DOI 10.3390/idr16010005
  2. Letermovir should be first-line cytomegalovirus prophylaxis in lung transplant recipients.
    Mezochow AK, Clausen E, Whitaker K, Claridge T, et al · · 2025 · cited 7× · PMID 39884651 · DOI 10.1016/j.ajt.2025.01.038
  3. Cytomegalovirus infections in thoracic organ transplant recipients: Updates on prevention, treatment, and immune monitoring.
    Collis BJ, Heldman MR, Wolfe CR. · · 2026 · PMID 41695191 · DOI 10.1016/j.jhlto.2025.100449

Verify or expand the search:

Other recruiting trials for Cytomegalovirus Infections

Currently open trials in the same condition.

Other University of Pennsylvania trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06066957.

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