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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History