[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611061":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":63,"collaborators":27,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":27,"enrollmentInfo":75,"targetDuration":27,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SOC antiviral plus placebo","PLACEBO_COMPARATOR","Patients will receive the standard of care (SOC) antiviral therapy along with a placebo drug. The placebo drug will be administered for three weeks, while the SOC antiviral duration and dosage will be at the discretion of the treating physician.",[13,14],"Drug: Placebo","Drug: Valganciclovir\u002FGanciclovir",{"label":16,"type":17,"description":18,"interventionNames":19},"SOC antiviral plus letermovir active drug","EXPERIMENTAL","Patients will receive the standard of care (SOC) antiviral therapy in combination with letermovir. The letermovir active drug will be administered for three weeks, while the SOC antiviral treatment duration and dosage will be at the discretion of the treating physician.",[20,14],"Drug: Letermovir",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Letermovir","Letermovir (480mg) will be given orally as a loading dose every 12 hours for the first 24 hours, then one tablet per day for a total treatment duration of 21 days. Letermovir treatment will be started within 72 hours of starting SOC antiviral treatment as per the decision of the treating physician.",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Placebo","Placebo will be dosed the same as letermovir: one tablet every 12 hours for the first 24 hours, then one tablet per day for total treatment duration of 21 days.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Valganciclovir\u002FGanciclovir","Ganciclovir or its oral prodrug, valganciclovir will be administered as the standard of care antiviral therapy. Its duration will be at the discretion of the treatment physician but is typically given until clearance of viremia. The clinical definition of viral clearance is one negative viral load or two viral loads one week apart that are \\\u003C200 IU\u002FmL",[16,9],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Atul Humar, MD, FRCPC","CONTACT","416-340-4241","atul.humar@uhn.ca",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Health Network, Toronto General Hospital","RECRUITING","Toronto","Ontario","M5G 2C4","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":61,"email":62},"Ilona Bahinskaya, MSc, CCRP","416-340-4800","4328","Ilona.Bahinskaya@uhn.ca",{"type":64,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100611061","phase-4-combination-letermovir-and-standard-of-care-antiviral-for-enhanced-antiviral-response-in-cytomegalovirus-infection-in-lung-transplant-recipients-100611061",false,"NCT07235683","Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients","Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients: A Pilot Trial","CLEAR-CMV","Inclusion Criteria:\n\n* Recipient of a lung transplant.\n* Has confirmed CMV viremia with a viral load ≥ 1000 IU\u002FmL and will receive or has just started SOC antiviral treatment in the past 72h as per the decision of the treating physician.\n\nExclusion Criteria:\n\n* Renal failure with Creatinine clearance \\\u003C15 mL\u002Fmin or requiring dialysis\n* Severe hepatic impairment (Child-Pugh Class C)\n* Participating in another interventional clinical trial\n* Combined transplant (e.g heart-lung, lung-liver)\n* Known allergy or contraindication to any of the antiviral medications\n* Known antiviral resistance.\n* Patient receiving cyclosporin, pimozide or ergot alkaloids (due to significant drug interaction with letermovir).\n* Patient receiving or expected to receive CMV immunoglobulin or IVIG during the initial three week treatment phase","ALL","18 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The primary objective of the CLEAR-CMV trial is to evaluate the efficacy of letermovir therapy plus standard of care (SOC) antiviral compared to SOC plus placebo in achieving clearance of CMV viremia by week 3 in lung transplant recipients with active CMV infection.",[83,84],"CMV","Lung Transplant Recipient",[86,87],"CMV Disease","Lung Transplant","2026-02-12",{"date":90,"type":91},"2026-02-17","ACTUAL",{"date":93,"type":91},"2025-12-24",{"date":95,"type":77},"2027-08",{"name":5,"class":6},1]