[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100219726":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":30,"locations":30,"responsibleParty":35,"collaborators":30,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":30,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":46,"maxAge":30,"enrollmentInfo":47,"targetDuration":30,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":30,"overallStatus":56,"whyStopped":30,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":30},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Letermovir","EXPERIMENTAL","Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.",[13],"Drug: Letermovir",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Letermovir 240 mg \u002F 480 mg tablets, or 240 mg \u002F 480 mg intravenous solution in 250 mL to be infused over 60 minutes.",[9],[26],"MK-8228",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo tablets, or intravenous solution in 250 mL to be infused over 60 minutes.",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Medical Director","STUDY_DIRECTOR",{"type":36,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100219726","phase-3-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-8228-001-100219726",true,"NCT02137772","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)","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","Inclusion Criteria:\n\n* Has documented seropositivity for CMV within 1 year before hematopoietic stem cell transplant (HSCT)\n* Receiving first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant)\n* 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\n* Able to read, understand, and complete questionnaires and diaries\n\nExclusion Criteria:\n\n* Received a previous allogeneic HSCT (previous autologous HSCT is acceptable)\n* History of CMV end-organ disease within 6 months before randomization\n* 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.\n* Received the following within 7 days before screening or plans to receive during the study: ganciclovir, valganciclovir, foscarnet, acyclovir, valacyclovir, or famciclovir\n* 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\n* Has suspected or known hypersensitivity to ingredients of MK-8228 (letermovir) formulations\n* Has severe hepatic insufficiency within 5 days before randomization\n* Has end-stage renal impairment\n* Has an uncontrolled infection on the day of randomization\n* Requires mechanical ventilation or is hemodynamically unstable at the time of randomization\n* 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\n* 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)\n* 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\n* Is expecting to donate eggs or sperm from the time of consent through 90 days after the last dose of study drug\n* 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\n* Has previously participated in a MK-8228 (letermovir) study\n* Has, is, or is planning (during the study) to participate in any study involving administration of a CMV vaccine or another CMV investigational agent\n* Is a user of recreational or illicit drugs or has a recent history (\\\u003C=1 year) of drug or alcohol abuse or dependence",false,"ALL","18 Years",{"count":48,"type":49},570,"ACTUAL","INTERVENTIONAL",[52],"PHASE3","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.",[55],"Prevention of CMV Infection or Disease","COMPLETED","2019-08-29",{"date":59,"type":49},"2019-09-11",{"date":61,"type":49},"2014-06-06",{"date":63,"type":49},"2016-11-21",{"name":5,"class":6}]