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: 17 Jun 2018

At a glance

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

    • 17 Jun 2018 Results assessing the impact of letermovir prophylaxis on the rate of rehospitalization in adult CMV seropositive allogeneic Hsct recipients, presented at the 23rd Congress of the European Haematology Association.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top