[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627043":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":12,"collaborators":10,"id":14,"slug":15,"hasResults":16,"nctId":17,"briefTitle":18,"officialTitle":19,"acronym":10,"eligibilityCriteria":20,"healthyVolunteers":16,"sex":21,"minAge":22,"maxAge":10,"enrollmentInfo":23,"targetDuration":10,"studyType":26,"phases":10,"briefSummary":27,"conditions":28,"keywords":10,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":10},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"CMV high risk patients after transplantation",null,"For enrolled subjects, at 3 months after transplantation, apply a predictive model incorporating CMV-specific immune reconstitution to evaluate the risk of CMV infection after discontinuation of letermovir. Based on the prediction results, define low-risk, intermediate-risk, and high-risk categories. For low-risk patients, direct discontinuation of letermovir is recommended; for intermediate-risk patients, discontinuation may be considered, but close monitoring of peripheral blood CMV-DNA is required after discontinuation; for high-risk patients, extending letermovir treatment until 200 days after transplantation is recommended.",{"type":13,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100627043","reducing-post-letermovir-cmv-infection-efficacy-of-an-immune-reconstitution-based-scoring-system-to-guide-prophylaxis-duration-100627043",false,"NCT07443501","Reducing Post-Letermovir CMV Infection: Efficacy of an Immune-Reconstitution-Based Scoring System to Guide Prophylaxis Duration","Evaluation of the Efficacy of a Cytomegalovirus-Specific Immune Reconstitution-Incorporated Scoring System in Guiding the Duration of Antiviral Prophylaxis to Reduce Cytomegalovirus Infection Following Letermovir Discontinuation","Inclusion Criteria:\n\n* (1) Recipients who meet either of the following conditions:\n\n  1. CMV IgG-positive recipients undergoing HLA-haploidentical hematopoietic stem cell transplantation (HSCT).\n  2. CMV IgG-negative recipients receiving a graft from a CMV IgG-positive donor, and who have received letermovir as CMV prophylaxis post-transplant without prior discontinuation.\n* (2) Plasma CMV-DNA level below the lower limit of detection (local threshold: 400 copies\u002FmL) within 5 days before enrollment.\n* (3) Age ≥ 18 years.\n* (4) Ability to provide written informed consent independently.\n* (5) Negative for HIV, HBV, and HCV.\n* (6) Written informed consent must be provided before initiation of any study procedure. Consent may be provided by the patient or a legally authorized representative if, in the investigator's judgment, obtaining consent directly from the patient is not in the patient's best medical interest.\n\nExclusion Criteria:\n\n* (1) Prior clinical diagnosis of CMV infection, CMV disease, or CMV viremia before enrollment;\n* (2) Received ganciclovir, valganciclovir, foscarnet, acyclovir (oral dose \\>3200 mg daily, or intravenous dose \\>25 mg\u002Fkg daily), valacyclovir (oral dose \\>3000 mg daily), or famciclovir (oral dose \\>1500 mg daily) within 7 days before enrollment;\n* (3) Received the following treatments within 30 days before enrollment: cidofovir, CMV hyperimmune globulin, any experimental anti-CMV therapy or biologics;\n* (4) Presence of uncontrolled infection, requirement for mechanical ventilation, or hemodynamic instability at enrollment;\n* (5) Suffering from mental illness or other conditions that prevent compliance with study treatment and monitoring requirements;\n* (6) Inability or unwillingness to sign the informed consent form;\n* (7) Other special circumstances deemed ineligible by the investigator.","ALL","18 Years",{"count":24,"type":25},1114,"ESTIMATED","OBSERVATIONAL","With the increasing use of letermovir and considering that haploidentical hematopoietic stem cell transplantation (haplo-HSCT) predominates in China alongside a high CMV seroprevalence in the population, multiple domestic centers have reported cases of CMV infection after letermovir discontinuation. Currently, there is no clear definition for the high-risk population who may benefit from extended letermovir prophylaxis. This study aims to utilize CMV-specific immune reconstitution to identify high-risk individuals for CMV infection after letermovir cessation post-transplant, thereby guiding the timing of letermovir discontinuation and balancing the risks and safety associated with prolonged prophylaxis.",[29],"CMV Infection","NOT_YET_RECRUITING","2026-02-27",{"date":33,"type":34},"2026-03-02","ACTUAL",{"date":36,"type":25},"2026-03-14",{"date":38,"type":25},"2027-12-14",{"name":5,"class":6}]