A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients

Trial Profile

A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jan 2018

At a glance

  • Drugs Letermovir (Primary) ; Letermovir (Primary)
  • Indications Cytomegalovirus infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 08 Jan 2018 According to an AiCuris media release, the European Commission (EC) granted marketing authorization for PREVYMIS™ (letermovir) for prophylaxis (prevention) of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). EC approval allows for marketing in all 28 European Union (EU) member states, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
    • 15 Dec 2017 This trial was also planned in Australia and Israel, according to European Clinical Trials Database.
    • 14 Dec 2017 Results published in the Merck & Co Media Release.
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