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A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

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Trial Profile

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Oct 2023

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At a glance

  • Drugs Letermovir (Primary) ; Letermovir (Primary) ; Aciclovir; Aciclovir; Ciclosporin; Ganciclovir; Valganciclovir
  • Indications Cytomegalovirus infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 17 Oct 2023 According to a Merck and Co media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PREVYMIS (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative) based on data from this trial.
  • 06 Jun 2023 Results presented in the Merck & Co Media Release.
  • 06 Jun 2023 According to a Merck and Co media release, the U.S. Food and Drug Administration (FDA) has approved a new indication for PREVYMIS (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review, based on data from this trial.

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