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A Phase 3 randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of letermovir (LET) prophylaxis when extended from 100 days to 200 days post transplant in cytomegalovirus (CMV) seropositive recipients (R+) of an allogenic hematopoietic stem cell transplant (HSCT)

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Trial Profile

A Phase 3 randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of letermovir (LET) prophylaxis when extended from 100 days to 200 days post transplant in cytomegalovirus (CMV) seropositive recipients (R+) of an allogenic hematopoietic stem cell transplant (HSCT)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2024

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At a glance

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

Most Recent Events

  • 17 Oct 2023 According to a Merck and Co media release, based on this study CHMP has recommended the approval for extending dosing for PREVYMIS from 100 days to 200 days following transplant in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease. The CHMPs recommendations will now be reviewed by the EC for marketing authorization in the European Union (EU) and a final decision is expected this year.
  • 17 Feb 2023 Results presented in the Merck and Co Media Release.
  • 17 Feb 2023 Primary endpoint has been met. (Percentage of Participants With Clinically Significant CMV Infection From Week 14 (~100 Days) Post-transplant Through Week 28 (~200 Days) Post-transplant), according to a Merck and Co media release.

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