[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416765":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":147,"collaborators":31,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":151,"sex":157,"minAge":158,"maxAge":31,"enrollmentInfo":159,"targetDuration":31,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":31,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"SymBio Pharmaceuticals","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"BCV 0.2mg\u002Fkg BIW","EXPERIMENTAL","BCV: 0.2 mg\u002Fkg administered as a continuous IV infusion over 2 hours",[13],"Drug: BCV",{"label":15,"type":10,"description":16,"interventionNames":17},"BCV 0.3mg\u002Fkg BIW","BCV: 0.3 mg\u002Fkg administered as a continuous IV infusion over 2 hours",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"BCV 0.4 mg\u002Fkg BIW","BCV: 0.4 mg\u002Fkg administered as a continuous IV infusion over 2 hours",[13],{"label":23,"type":10,"description":20,"interventionNames":24},"BCV 0.4 mg\u002Fkg QW",[13],[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","BCV","Brincidofovir (BCV) is a lipid conjugate of the antiviral cidofovir that enables optimal intracellular levels of the active drug.",[9,15,19,23],null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Kohji Shimasaki","CONTACT","+81-3-6684-6616","MedInfo@symbiopharma.com",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Rochelle Maher","+1-917-656-6951","rmaher@symbiopharma.com",[43,57,63,71,80,90,99,109,118,128,138],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":31},"Research Site","RECRUITING","Los Angeles","California","90027","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-118.24368,34.05223,{"lat":55,"lon":54},{"facility":44,"status":58,"city":46,"state":47,"zip":59,"country":49,"countryCode":50,"cosmosGeoPoint":60,"geoPoint":62,"contacts":31},"COMPLETED","90095",{"type":52,"coordinates":61},[54,55],{"lat":55,"lon":54},{"facility":44,"status":58,"city":64,"state":47,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":31},"San Francisco","94158",{"type":52,"coordinates":67},[68,69],-122.41942,37.77493,{"lat":69,"lon":68},{"facility":44,"status":45,"city":72,"state":73,"zip":74,"country":49,"countryCode":50,"cosmosGeoPoint":75,"geoPoint":79,"contacts":31},"Chicago","Illinois","60637",{"type":52,"coordinates":76},[77,78],-87.65005,41.85003,{"lat":78,"lon":77},{"facility":81,"status":45,"city":82,"state":83,"zip":84,"country":49,"countryCode":50,"cosmosGeoPoint":85,"geoPoint":89,"contacts":31},"University of Nebraska Medical Center","Omaha","Nebraska","68198",{"type":52,"coordinates":86},[87,88],-95.94043,41.25626,{"lat":88,"lon":87},{"facility":44,"status":45,"city":91,"state":92,"zip":93,"country":49,"countryCode":50,"cosmosGeoPoint":94,"geoPoint":98,"contacts":31},"Durham","North Carolina","27710",{"type":52,"coordinates":95},[96,97],-78.89862,35.99403,{"lat":97,"lon":96},{"facility":100,"status":45,"city":101,"state":102,"zip":103,"country":49,"countryCode":50,"cosmosGeoPoint":104,"geoPoint":108,"contacts":31},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":52,"coordinates":105},[106,107],-84.51439,39.12711,{"lat":107,"lon":106},{"facility":44,"status":45,"city":110,"state":111,"zip":112,"country":49,"countryCode":50,"cosmosGeoPoint":113,"geoPoint":117,"contacts":31},"Philadelphia","Pennsylvania","19104",{"type":52,"coordinates":114},[115,116],-75.16362,39.95238,{"lat":116,"lon":115},{"facility":119,"status":45,"city":120,"state":121,"zip":122,"country":49,"countryCode":50,"cosmosGeoPoint":123,"geoPoint":127,"contacts":31},"St. Jude Children's Research Hospital","Memphis","Tennessee","38105",{"type":52,"coordinates":124},[125,126],-90.04898,35.14953,{"lat":126,"lon":125},{"facility":129,"status":45,"city":130,"state":131,"zip":132,"country":49,"countryCode":50,"cosmosGeoPoint":133,"geoPoint":137,"contacts":31},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":52,"coordinates":134},[135,136],-95.36327,29.76328,{"lat":136,"lon":135},{"facility":44,"status":45,"city":139,"state":140,"zip":141,"country":49,"countryCode":50,"cosmosGeoPoint":142,"geoPoint":146,"contacts":31},"Seattle","Washington","98109",{"type":52,"coordinates":143},[144,145],-122.33207,47.60621,{"lat":145,"lon":144},{"type":148,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100416765","phase-2-a-phase-2a-study-of-iv-bcv-in-subjects-with-adenovirus-infection-100416765",false,"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.","ALL","2 Months",{"count":160,"type":161},52,"ESTIMATED","INTERVENTIONAL",[164],"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",[167,168],"Adenovirus Infections","Cytomegalovirus Infection","2024-06-20",{"date":171,"type":172},"2024-06-21","ACTUAL",{"date":174,"type":172},"2021-08-16",{"date":176,"type":161},"2026-09-30",{"name":5,"class":6},11]