[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cytomegalovirus-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cytomegalovirus-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100586501","burden-of-cytomegalovirus-reactivation-in-pediatric-patients-after-allogeneic-hematopoietic-stem-cell-transplantation-100586501",false,"NCT06916195","Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation","CMV PED Study - A Retrospective Observational Study To Understand The Clinical And Economic Burden Associated With Cytomegalovirus Reactivation and Related Health Outcomes In Pediatric Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation In Italy","CMV PED","Inclusion Criteria:\n\n* Patients from birth to less than 18 years of age (at the moment of the allogeneic HSCT);\n* Patients who received allogeneic HSCT between January 2018 and June 2020;\n* Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \\& Privacy Form (ICF), if applicable.\n\nExclusion Criteria:\n\n* Letermovir use at any time","ALL","0 Years","18 Years",{"count":21,"type":22},230,"ESTIMATED","OBSERVATIONAL","This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and clinical management of pediatric patients undergoing allogeneic Hematopoietic Stem Cells Transplantation in Italy.",[26,27],"Cytomegalovirus Infection","Hematopoietic Stem Cells Transplantation","RECRUITING","2026-03-31",{"date":31,"type":32},"2026-04-06","ACTUAL",{"date":34,"type":32},"2025-05-09",{"date":36,"type":22},"2026-07-15",{"name":38,"class":39},"MSD Italia S.r.l.","INDUSTRY",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100541794","phase-3-letermovir-based-dual-therapy-for-treatment-of-cytomegalovirus-infections-100541794","NCT06334497","Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections","Letermovir\u002FValganciclovir Combination Versus Valganciclovir Monotherapy for Treatment of Cytomegalovirus (CMV) Infections in Kidney Transplant Recipients","LUCY-1","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Weight ≥ 30 kg\n3. Kidney transplant recipient\n4. Have a documented CMV infection or disease, with (i) a screening value of CMV DNA ≥ 3000 IU\u002FmL in whole blood or plasma in 2 consecutive assessments separated by ≥ 1 day, as determined by local laboratory quantitative polymerase chain reaction (qPCR). Both samples should be taken within 14 days prior to randomization with the second sample obtained within 5 days prior to randomization OR (ii) a screening value of CMV DNA ≥ 30000 IU\u002FmL in whole blood or plasma, as determined by local laboratory quantitative polymerase chain reaction (qPCR), in 1 sample obtained within 5 days prior to randomization\n5. Eligible for treatment with oral valganciclovir, per investigator's judgment\n6. For patients of childbearing age (following menarche): negative bHCG and effective method of contraception (sexual abstinence, hormonal contraception containing ethinylestradiol and levonorgestrel, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) until 30 days after the end of relevant systemic exposure (week 13).\n\n   For male an effective method of contraception (sexual abstinence, condom) until 90 days after the end of relevant systemic exposure (week 13).\n7. Have life expectancy of ≥ 8 weeks\n8. French speaking\n9. Affiliated to social security regime or an equivalent system\n10. Informed consent and signed\n\nExclusion Criteria:\n\n1. Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to antiviral treatment, to the best knowledge of the investigator.\n2. Have a CMV infection that is known to be genotypically resistant to valganciclovir and\u002For letermovir on documented evidence.\n3. Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir or maribavir) for the current CMV infection for longer than 72 hours. However, patients experiencing CMV infection while receiving ganciclovir or valganciclovir prophylaxis (i.e. at prophylactic dosages) or letermovir prophylaxis can be included.\n4. Have an eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m² (using the CKD-EPI Creatinine Equation (2009)).\n5. Have serum aspartate aminotransferase (AST) ≥ 5 times higher than the upper limit of normal (ULN), or serum alanine aminotransferase (ALT) ≥ 5 times the ULN, or total bilirubin ≥ 3 times the ULN (except for documented Gilbert's syndrome). Note: Subjects with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT ≥ 5 times ULN\n6. Have a severe chronic liver disease (Child-Pugh Class C)\n7. Have a known human immunodeficiency virus (HIV) infection with plasma HIV RNA ≥ 50 copies\u002FmL within the 3 months before inclusion.\n8. Require mechanical ventilation or vasopressors for hemodynamic support.\n9. Be pregnant or breastfeeding.\n10. Have received anti-CMV vaccine at any time.\n11. Be receiving leflunomide or artesunate when study treatment is initiated.\n12. Be receiving strong inhibitors or inducers of hepatic CYP enzymes including rifampicin, phenytoin, clarithromycin, ritonavir, or cobicistat or St. John's wort (Hypericum perforatum) when study treatment is initiated.\n13. Be receiving efavirenz, etravirine, nevirapine, lopinavir, pimozine, ergot alkaloids, dabigatran, atorvastatine (at a daily dose \\> 20mg, and \u002F or if co-administered with cyclosporin A), pravastatin ( if co-administered with cyclosporin A), simvastatine, rosuvastatine, pitavastatine or imipenem-cilastatine when study treatment is initiated.\n14. Have known hereditary intolerance to galactose, with lactose Lapp deficiency, glucose or galactose malabsorption syndrome.\n15. Have known hypersensitivity to letermovir or to an excipient for a study treatment.\n16. Have any clinically significant medical or surgical condition that in the investigator's opinion could interfere with the interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the subject.\n17. Participation to another clinical trial on medicinal products for human use\n18. Have an absolute neutrophil count less than 500 cells\u002Fµl, or platelet count less than 25,000\u002Fµl, or haemoglobin less than 8 g\u002Fdl",{"count":50,"type":22},80,"INTERVENTIONAL",[53],"PHASE3","The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment.",[26],[57,58],"Cytomegalovirus infection","Cytomegalovirus disease","2025-12-29",{"date":61,"type":32},"2026-01-02",{"date":63,"type":32},"2024-08-14",{"date":65,"type":22},"2027-11",{"name":67,"class":68},"Assistance Publique - Hôpitaux de Paris","OTHER",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":51,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100416765","phase-2-a-phase-2a-study-of-iv-bcv-in-subjects-with-adenovirus-infection-100416765","NCT04706923","A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection","A Phase IIa, Open-label, Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Administration of Brincidofovir in Subjects With Adenovirus Infection or Cytomegalovirus Infection","ATHENA","Inclusion Criteria:\n\n* Male or female, aged 2 months and older at the time of informed consent.\n* AdV DNA viremia \\>10,000 copies\u002FmL from a single sample, or 2 samples greater than 48 hours apart with the second result higher than the first and both greater than 1000 copies\u002FmL, from the data obtained from the designated central virology laboratory of the local laboratory using the blood sample(s) collected informed consent has been obtained and within 7 days prior to Day 1 (AdV DNA viremia results collected within the 7 day window, but prior to consent may be used if the Informed Consent Form (ICF) signed by the subject provides approval) . CMV viremia with or without evidence of tissue invasive CMV disease. For laboratory results that are generated in units other than copies\u002FmL or IU\u002FmL, please refer to the testing laboratory for guidance on the appropriate conversion calculation.\n* Either (a) have disseminated AdV disease or (b) have an underlying immunocompromised state, and have asymptomatic AdV infection or localized AdV disease.\n* In the judgment of the investigator, be in a serious condition to be treated with intravenous cidofovir for AdV.\n\nExclusion Criteria:\n\n* Subjects who weigh ≥120 kg.\n* NIH\u002FNCI CTCAE (United States \\[US\\] National Institutes of Health \\[NIH\\]\u002FNational Cancer Institute) Grade 2 or higher diarrhea (i.e., increase of ≥ 4 stools per day over usual pre-transplant stool output) within 7 days prior to Day 1.\n* NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1.\n* NIH Stage 2 or higher acute GVHD of the liver function (i.e., bilirubin \\>3 mg\u002FdL \\[SI: \\>51 μmol\u002FL\\]) within 7 days prior to Day 1.\n* NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea \\>556 mL\u002Fm2\u002Fday for pediatric subjects \\[or \\>1000 mL\u002Fday for young adults as applicable, at centers in the United States only\\], or severe abdominal pain with or without ileus) within 7 days prior to Day 1.","2 Months",{"count":79,"type":22},52,[81],"PHASE2","The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg\u002Fkg, 0.3 mg\u002Fkg or 0.4 mg\u002Fkg dosed twice weekly (BIW) or 0.4 mg\u002Fkg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV",[84,26],"Adenovirus Infections","2024-06-20",{"date":87,"type":32},"2024-06-21",{"date":89,"type":32},"2021-08-16",{"date":91,"type":22},"2026-09-30",{"name":93,"class":39},"SymBio Pharmaceuticals",11]