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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 15, 2026 → Dec 15, 2026
See other at-risk trials from University of Pennsylvania

Record History

  1. Enrollment closed, study ongoing Primary completion pushed from Aug 15, 2026 to Dec 15, 2026 · Completion pushed from Aug 15, 2026 to Jan 31, 2027 · Eligibility criteria expanded, about 30 words · 3 more Show 6 more changesShow less
    • Primary completion pushed from Aug 15, 2026 to Dec 15, 2026
    • Completion pushed from Aug 15, 2026 to Jan 31, 2027
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Site details revised
    • Collaborators: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv6
  3. Eligibility criteria expanded, about 98 words Secondary endpoints revised (6) · Site contact updatedv5 Show 2 more changesShow less
    • Secondary endpoints revised (6)
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 15, 2024 to Apr 4, 2024 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 15, 2024 to Apr 4, 2024
    • Site details revised
  5. Start date: Feb 15, 2024 to Mar 15, 2024v3
  6. Start date: Jan 1, 2024 to Feb 15, 2024 Primary completion date: Jan 1, 2027 to Aug 15, 2026 · Completion date: Jun 1, 2027 to Aug 15, 2026v2 Show 2 more changesShow less
    • Primary completion date: Jan 1, 2027 to Aug 15, 2026
    • Completion date: Jun 1, 2027 to Aug 15, 2026
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06066957
Lead Sponsor University of Pennsylvania
Collaborators: Merck Sharp & Dohme LLC
Conditions Cytomegalovirus Infections, Transplant-Related Disorder
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov