[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SymBio Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100622726","phase-3-a-phase-3-trial-to-compare-iv-bcv-versus-iv-cdv-for-treatment-of-adenovirus-infection-after-allo-hct-100622726",false,"NCT07387367","A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT","A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir Versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)","ENOVIA","Inclusion Criteria:\n\n1. Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form.\n2. Subject\u002FGuardian willing and able to understand and provide written informed consent to participate in the study.\n3. In the investigator's judgement, the subject's clinical condition justifies treatment with IV BCV or IV CDV for AdV infection.\n4. Has adenoviremia, based on any of:\n\n   * AdV viremia DNA ≥10,000 IU\u002FmL, OR\n   * Two consecutive and rising AdV viremia DNA results of ≥1,000 IU\u002FmL at screening, OR\n   * AdV viremia DNA of ≥1,000 IU\u002FmL, AND\n\n1\\. Lymphocyte count \\\u003C180\u002Fmm3, OR 2. Received T cell depletion, cord blood, or haploidentical transplant, OR 3. prior alemtuzumab, OR 4. anti-thymocyte globulin (ATG)\n\nExclusion Criteria:\n\n1. Subject received an allo-HCT with a matched sibling donor\n2. Subject received more than 5 mg\u002Fkg of CDV for any reason in the 21 days prior to first dose of study drug.\n3. Subject is allergic or hypersensitive to IV BCV or IV CDV or any of their components.\n4. Subject received anti-AdV-specific cell-based therapy within 3 weeks prior to W1D1 or an anti-AdV vaccine at any time.\n5. Subject has participated in any other investigational study within 30 days (or within 5.5 half-lives of the investigational product, whichever is longer) before signing the informed consent form (ICF), is currently participating in another interventional treatment trial with an investigational agent or is using an investigational device at the time of Screening.","ALL","2 Months",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia. A virologic response-driven approach to duration of treatment will be evaluated, in which randomized subjects are treated with either BCV or CDV until AdV viremia is confirmed as undetectable or until a maximum of 12 weeks of therapy, whichever occurs first. All subjects will be followed for a total of 24 weeks post-randomization, regardless of treatment assignment. Subjects will be assessed on a weekly basis through the end of treatment visit (EOT). Additional assessments will be performed at the test of cure (TOC) visit, which is 4 weeks after the last dose of study drug and at Weeks 12 and 24 post W1D1.",[27],"Adenovirus Infections",[29,30,31,32,33,15],"Brincidofovir","Cidofovir","Adenovirus","allo-HCT","BCV-PA02","RECRUITING","2026-04-23",{"date":37,"type":38},"2026-04-27","ACTUAL",{"date":40,"type":38},"2026-03-17",{"date":42,"type":21},"2028-06-30",{"name":44,"class":45},"SymBio Pharmaceuticals","INDUSTRY",61,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"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.",{"count":56,"type":21},52,[58],"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",[27,61],"Cytomegalovirus Infection","2024-06-20",{"date":64,"type":38},"2024-06-21",{"date":66,"type":38},"2021-08-16",{"date":68,"type":21},"2026-09-30",{"name":44,"class":45},11,""]