letermovir (mk-8228) versus placebo in the prevention of clinically-significant cytomegalovirus (cmv) infection in adult, cmv-seropositive allogeneic hematopoietic stem cell transplant recipients (mk-8228-001)

Conditions: Prevention of CMV Infection or Disease

Summary: the study evaluated the efficacy and safety of letermovir (mk-8228) for the prevention of clinically-significant cmv infection in adult, cmv-seropositive recipients of allogeneic hematopoietic stem cell transplant (hsct). the hypothesis being tested was that mk-8228 is superior to placebo in the prevention of clinically-significant cmv infection through week 24 post-transplant.


Eligibility criteria:
inclusion criteria: * has documented seropositivity for cmv within 1 year before hematopoietic stem cell transplant (hsct) * receiving first allogeneic hsct (bone marrow, peripheral blood stem cell, or cord blood transplant) * female or male participant who is not of reproductive potential, or, if of reproductive potential, agrees to true abstinence or to use (or have their partner use) 2 acceptable methods of birth control from the time of consent through 90 days after the last dose of study drug * able to read, understand, and complete questionnaires and diaries exclusion criteria: * received a previous allogeneic hsct (previous autologous hsct is acceptable) * history of cmv end-organ disease within 6 months before randomization * has evidence of cmv viremia (if tested) at any time from either signing of the informed consent form or the hsct procedure, whichever is earlier, until the time of randomization. * received the following within 7 days before screening or plans to receive during the study: ganciclovir, valganciclovir, foscarnet, acyclovir, valacyclovir, or famciclovir * received the following within 30 days before screening or plan to receive during the study: cidofovir, cmv hyper-immune globulin, any investigational cmv antiviral agent or biological therapy * has suspected or known hypersensitivity to ingredients of mk-8228 (letermovir) formulations * has severe hepatic insufficiency within 5 days before randomization * has end-stage renal impairment * has an uncontrolled infection on the day of randomization * requires mechanical ventilation or is hemodynamically unstable at the time of randomization * has documented positive results for human immunodeficiency virus (hiv) antibody, hepatitis c virus (hcv) antibody with detectable hcv ribonucleic acid, or hepatitis b surface antigen (hbsag) within 90 days before randomization * has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (for example, lymphoma) * is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 90 days after the last dose of study drug * is expecting to donate eggs or sperm from the time of consent through 90 days after the last dose of study drug * has participated in a study with an unapproved investigational compound (monoclonal antibodies are excepted) or device within 28 days of the first dose of study drug * has previously participated in a mk-8228 (letermovir) study * has, is, or is planning (during the study) to participate in any study involving administration of a cmv vaccine or another cmv investigational agent * is a user of recreational or illicit drugs or has a recent history (\<=1 year) of drug or alcohol abuse or dependence