[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-cytomegaloviral-cmv-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-cytomegaloviral-cmv-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100482635","phase-2-cmv-ctls-in-neonates-with-cmv-infection-100482635",false,"NCT05564598","CMV CTLs in Neonates With CMV Infection","A Phase II Open-Label Randomized Study of Anti-Viral Antibiotic Therapy With and Without Familial (Maternal) Cytomegalovirus (CMV) Cytotoxic T Lymphocytes (CTLs) in Neonates With Moderate\u002FSevere Maternal Acquired CMV Infection","Inclusion Criteria:\n\n* Age: ≤ 21 days of life\n* Birth Weight: ≥ 2500 gms\n* Gestational age: ≥ 34 weeks of age\n* Diagnosis of CMV viremia, viruria, and\u002For infection:Either one or more:\n\nElevated CMV by RT-PCR in urine, saliva, CSF, or plasma; and\u002For Positive urine culture for CMV\n\n\\- Moderate or Severe CMV Disease\n\nAny one or more of the following attributable to congenital CMV infection:\n\n* Thrombocytopenia (≤ 50,000 mm3)\n* Multiple petechiae\n* Hepatomegaly\n* Splenomegaly\n* Intrauterine growth retardation\n* Increased transaminases\n* Increased bilirubin\n* Microcephaly\n* Ventriculomegaly\n* Intracerebral calcifications\n* Periventricular echogenicity\n* Cortical or cerebral malformation\n* Chorioretinitis\n* Severe neonatal hearing loss\n* CMV DNA by PCR in CNS\n* Increased WBC for age in CNS\n\n  * Minimal Organ Criteria Hematological: ANC ≥ 750\u002Fmm3, HgB ≥ 8gm\u002Fdl, Platelets ≥ 20,000\u002Fkmm3 Renal: Serum creatinine ≤ 1.0 mg\u002Fdl Hepatic: ALT\u002FSGOT ≤3x upper normal limits\n  * Donor Availability: Maternal donor available with a T-cell response CMV MACS® PepTivators. the donor is considered suitable if the percentage of IFN-gamma+ T cells is \\> 0.01% after stimulation with PepTivators.\n\nExclusion Criteria -\n\n* Patient receiving steroids (\\> 0.5 mg\u002Fkg prednisone equivalent) on the same day of CMV CTL infusion. Antenatal steroids for lung maturation will have been cleared prior to CMV diagnosis.\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of neonatal CMV viremia and\u002For infection.\n* Any medical condition that could compromise participation in the study according to the investigator's assessment.\n* Known history of HIV infection in the mother.\n* Patient's legally authorized representative unwilling or unable to comply with the protocol or unable to give informed consent.","ALL","0 Days","21 Days",{"count":20,"type":21},23,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened.\n\nAll patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if found to be safe, will proceed to cohort 2 for randomization to receive antiviral therapy with or without CMV CTLs.\n\nFunding source: FDA OOPD",[27],"Congenital Cytomegaloviral (CMV) Disease","RECRUITING","2026-03-24",{"date":31,"type":32},"2026-03-30","ACTUAL",{"date":34,"type":32},"2023-07-01",{"date":36,"type":21},"2028-10-31",{"name":38,"class":39},"New York Medical College","OTHER",4]