[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608277":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":29,"interventions":36,"overallOfficials":47,"centralContacts":51,"locations":57,"responsibleParty":277,"collaborators":22,"id":279,"slug":22,"hasResults":280,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":22,"eligibilityCriteria":284,"healthyVolunteers":280,"sex":285,"minAge":22,"maxAge":286,"enrollmentInfo":287,"targetDuration":22,"studyType":290,"phases":291,"briefSummary":293,"conditions":294,"keywords":22,"overallStatus":60,"whyStopped":22,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Area Under the Curve From Time 0 to 24 Hours (AUC0-24)","Blood samples will be collected at multiple time points to estimate AUC0-24","Day 7: Predose and at designated timepoints post-dose (up to 24 hours)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Percentage of Participants Who Experience an Adverse Event (AE)","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported.","Up to 21 days",{"measure":19,"description":20,"timeFrame":21},"Percentage of Participants Who Discontinue Study Intervention Due to an AE","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study treatment due to an AE is reported.","Up to 7 days",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"NA","SINGLE_GROUP","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE",[30],{"label":31,"type":32,"description":33,"interventionNames":34},"Weight-banded letermovir dosing","EXPERIMENTAL","Participants who are between 4 and 52 weeks post-KT will receive letermovir for 7 consecutive days.",[35],"Drug: Letermovir",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Letermovir","Administered orally (as tablets\u002Fpellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.",[31],[43,44,45,46],"MK-8228","AIC246","AIC001","PREVYMIS™",[48],{"name":49,"affiliation":5,"role":50},"Medical Director","STUDY_DIRECTOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":22,"email":56},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[58,76,89,101,113,125,138,151,164,177,190,202,214,226,239,251,264],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019)","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-86.80249,33.52066,{"lat":70,"lon":69},[73],{"name":74,"role":54,"phone":75,"phoneExt":22,"email":22},"Study Coordinator","205-638-9781",{"facility":77,"status":60,"city":78,"state":79,"zip":80,"country":64,"countryCode":65,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)","Los Angeles","California","90095",{"type":67,"coordinates":82},[83,84],-118.24368,34.05223,{"lat":84,"lon":83},[87],{"name":74,"role":54,"phone":88,"phoneExt":22,"email":22},"310-825-5225",{"facility":90,"status":60,"city":91,"state":79,"zip":92,"country":64,"countryCode":65,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Lucile Packard Children's Hospital ( Site 0001)","Palo Alto","94304",{"type":67,"coordinates":94},[95,96],-122.14302,37.44188,{"lat":96,"lon":95},[99],{"name":74,"role":54,"phone":100,"phoneExt":22,"email":22},"408-828-5120",{"facility":102,"status":60,"city":103,"state":79,"zip":104,"country":64,"countryCode":65,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"University of California Davis Health ( Site 0023)","Sacramento","95817",{"type":67,"coordinates":106},[107,108],-121.4944,38.58157,{"lat":108,"lon":107},[111],{"name":74,"role":54,"phone":112,"phoneExt":22,"email":22},"916-734-8036",{"facility":114,"status":60,"city":115,"state":79,"zip":116,"country":64,"countryCode":65,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"UCSF Medical Center at Mission Bay ( Site 0017)","San Francisco","94158",{"type":67,"coordinates":118},[119,120],-122.41942,37.77493,{"lat":120,"lon":119},[123],{"name":74,"role":54,"phone":124,"phoneExt":22,"email":22},"415-347-1885",{"facility":126,"status":60,"city":127,"state":128,"zip":129,"country":64,"countryCode":65,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Children's Hospital Colorado ( Site 0013)","Aurora","Colorado","80045",{"type":67,"coordinates":131},[132,133],-104.83192,39.72943,{"lat":133,"lon":132},[136],{"name":74,"role":54,"phone":137,"phoneExt":22,"email":22},"720-777-6263",{"facility":139,"status":60,"city":140,"state":141,"zip":142,"country":64,"countryCode":65,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"University of Miami School of Medicine ( Site 0021)","Miami","Florida","33136",{"type":67,"coordinates":144},[145,146],-80.19366,25.77427,{"lat":146,"lon":145},[149],{"name":74,"role":54,"phone":150,"phoneExt":22,"email":22},"305-243-4445",{"facility":152,"status":60,"city":153,"state":154,"zip":155,"country":64,"countryCode":65,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)","Chicago","Illinois","60611",{"type":67,"coordinates":157},[158,159],-87.65005,41.85003,{"lat":159,"lon":158},[162],{"name":74,"role":54,"phone":163,"phoneExt":22,"email":22},"312-227-2061",{"facility":165,"status":60,"city":166,"state":167,"zip":168,"country":64,"countryCode":65,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"University of Michigan ( Site 0014)","Ann Arbor","Michigan","48109",{"type":67,"coordinates":170},[171,172],-83.74088,42.27756,{"lat":172,"lon":171},[175],{"name":74,"role":54,"phone":176,"phoneExt":22,"email":22},"734-936-6280",{"facility":178,"status":60,"city":179,"state":180,"zip":181,"country":64,"countryCode":65,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007)","Minneapolis","Minnesota","55454",{"type":67,"coordinates":183},[184,185],-93.26384,44.97997,{"lat":185,"lon":184},[188],{"name":74,"role":54,"phone":189,"phoneExt":22,"email":22},"612-365-0013",{"facility":191,"status":60,"city":192,"state":180,"zip":193,"country":64,"countryCode":65,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Mayo Clinic - Rochester ( Site 0015)","Rochester","55905",{"type":67,"coordinates":195},[196,197],-92.4699,44.02163,{"lat":197,"lon":196},[200],{"name":74,"role":54,"phone":201,"phoneExt":22,"email":22},"507-254-1714",{"facility":203,"status":60,"city":204,"state":204,"zip":205,"country":64,"countryCode":65,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Morgan Stanley Children's Hospital ( Site 0018)","New York","10032",{"type":67,"coordinates":207},[208,209],-74.00597,40.71427,{"lat":209,"lon":208},[212],{"name":74,"role":54,"phone":213,"phoneExt":22,"email":22},"212-305-2500",{"facility":215,"status":60,"city":216,"state":204,"zip":217,"country":64,"countryCode":65,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Montefiore Einstein Center ( Site 0024)","The Bronx","10467",{"type":67,"coordinates":219},[220,221],-73.86641,40.84985,{"lat":221,"lon":220},[224],{"name":74,"role":54,"phone":225,"phoneExt":22,"email":22},"718-741-2426",{"facility":227,"status":60,"city":228,"state":229,"zip":230,"country":64,"countryCode":65,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Levine Children's Hospital ( Site 0022)","Charlotte","North Carolina","28203",{"type":67,"coordinates":232},[233,234],-80.84313,35.22709,{"lat":234,"lon":233},[237],{"name":74,"role":54,"phone":238,"phoneExt":22,"email":22},"704-446-4842",{"facility":240,"status":60,"city":241,"state":229,"zip":242,"country":64,"countryCode":65,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Duke University-Pediatrics ( Site 0008)","Durham","27110",{"type":67,"coordinates":244},[245,246],-78.89862,35.99403,{"lat":246,"lon":245},[249],{"name":74,"role":54,"phone":250,"phoneExt":22,"email":22},"919-684-6335",{"facility":252,"status":60,"city":253,"state":254,"zip":255,"country":64,"countryCode":65,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Cincinnati Children's Hospital Medical Center ( Site 0002)","Cincinnati","Ohio","45229",{"type":67,"coordinates":257},[258,259],-84.51439,39.12711,{"lat":259,"lon":258},[262],{"name":74,"role":54,"phone":263,"phoneExt":22,"email":22},"513-636-3017",{"facility":265,"status":60,"city":266,"state":267,"zip":268,"country":64,"countryCode":65,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Texas Children's Hospital ( Site 0005)","Houston","Texas","77030",{"type":67,"coordinates":270},[271,272],-95.36327,29.76328,{"lat":272,"lon":271},[275],{"name":74,"role":54,"phone":276,"phoneExt":22,"email":22},"832-824-4330",{"type":278,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100608277",false,"NCT07199465","A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)","A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is a recipient of a primary or secondary allograft kidney\n* Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local standard of care\n* Has stable kidney function posttransplant\n* Has undetectable CMV deoxyribonucleic acid (DNA) from a plasma or whole blood sample collected within 14 days prior to enrollment\n* Must be able to take (as assessed by the investigator) letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube (oral pellets only)\n* Does not have a condition that may interfere with the absorption of oral medication (e.g., vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment (Day 1) until the intensive pharmacokinetics (IPK) sampling is completed\n* Weighs ≥2.5 and \\\u003C40 kg at enrollment (Day 1)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has CMV disease or suspected CMV disease between screening and enrollment\n* Is on dialysis or plasmapheresis at the time of enrollment\n* Has evidence of CMV viremia at any time from screening until the time of enrollment\n* Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment\n* Is a multi-organ transplant recipient (e.g., kidney-pancreas)\n* Has any uncontrolled infection on the day of enrollment\n* Requires mechanical ventilation, or is hemodynamically unstable, at the time of enrollment\n* Has received or is receiving protocol-specified prohibited medications","ALL","17 Years",{"count":288,"type":289},40,"ESTIMATED","INTERVENTIONAL",[292],"PHASE1","Researchers are looking for a way to prevent cytomegalovirus (CMV) in children and adolescents who receive a kidney transplant (KT) and weigh less than 40 kilograms (88.2 pounds). The goals of the study are to:\n\n* Learn what happens to letermovir in the body over time\n* Learn about the safety of letermovir and if participants tolerate it",[295],"Cytomegalovirus Prophylaxis","2026-06-10",{"date":298,"type":299},"2026-06-12","ACTUAL",{"date":301,"type":299},"2026-03-30",{"date":303,"type":289},"2028-05-19",{"name":5,"class":6},17]