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: 08 Jan 2018
At a glance
- Drugs Letermovir (Primary) ; Letermovir (Primary)
- Indications Cytomegalovirus infections
- Focus Registrational; Therapeutic Use
- Sponsors Merck Sharp & Dohme
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History