[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645405":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":32,"responsibleParty":75,"collaborators":78,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":11,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":108,"whyStopped":11,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Komagome Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental:Foscenvivint Arm Description:Foscenvivint 280 mg\u002Fm2, once a week for 24 weeks","ACTIVE_COMPARATOR",null,[13],"Drug: Foscenvivint",[15],{"type":16,"name":17,"description":9,"armGroupLabels":18,"otherNames":11},"DRUG","Foscenvivint",[9],[20],{"name":21,"affiliation":22,"role":23},"Kiminori Kimura, MD","Tokyo Metropolitan Komagome Hospital","PRINCIPAL_INVESTIGATOR",[25,29],{"name":21,"role":26,"phone":27,"phoneExt":11,"email":28},"CONTACT","+81-3-3823-2101","kiminori_kimura@tmhp.jp",{"name":30,"role":26,"phone":27,"phoneExt":11,"email":31},"Akemi Ikoma","akemi_ikoma@tmhp.jp",[33,52,67],{"facility":34,"status":11,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hokkaido University Hospital","Sapporo","Hokkaido","060-8648","Japan","JP",{"type":41,"coordinates":42},"Point",[43,44],141.35,43.06667,{"lat":44,"lon":43},[47,51],{"name":48,"role":26,"phone":49,"phoneExt":11,"email":50},"Tomoyuki Endo, MD","+81-11-716-1161","t-endo@med.hokudai.ac.jp",{"name":48,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":53,"status":11,"city":54,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"National Hospital Organization Osaka National Hospital","Osaka","540-0006",{"type":41,"coordinates":57},[58,59],135.50107,34.69379,{"lat":59,"lon":58},[62,66],{"name":63,"role":26,"phone":64,"phoneExt":11,"email":65},"Ryotaro Sakamori, MD","+81-6-6942-1331","sakamori@gh.med.osaka-u.ac.jp",{"name":63,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":22,"status":11,"city":68,"state":69,"zip":70,"country":38,"countryCode":39,"cosmosGeoPoint":11,"geoPoint":11,"contacts":71},"Bunkyo-Ku","Tokyo","113-8677",[72,73,74],{"name":21,"role":26,"phone":27,"phoneExt":11,"email":28},{"name":30,"role":26,"phone":27,"phoneExt":11,"email":31},{"name":21,"role":23,"phone":11,"phoneExt":11,"email":11},{"type":76,"investigatorFullName":21,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Head, Department of Hepatology",[79,82],{"name":80,"class":81},"Japan Agency for Medical Research and Development","OTHER_GOV",{"name":83,"class":84},"Ohara Pharmaceutical Co., Ltd.","INDUSTRY","100645405","phase-2-a-phase-2-study-of-foscenvivint-in-liver-cirrhosis-patients-caused-by-hivhcv-co-infection-with-hemophilia-100645405",false,"NCT07681089","A Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV\u002FHCV Co-infection With Hemophilia.","A Multicenter, Single-Arm, Open-Label Phase 2 Study of Once-Weekly Foscenvivint in Patients With Liver Cirrhosis Due to HIV\u002FHCV Co-infection in the Setting of Hemophilia.","OP-724-H202","Inclusion Criteria:\n\n* Patients with hemophilia and liver cirrhosis caused by HIV\u002FHCV co-infection who meet both of the following criteria:\n\n  1. Patients who are serum HIV-RNA positive or HIV antibody positive, with HIV-RNA maintained at \\\u003C200 copies\u002FmL and a CD4-positive T lymphocyte count of ≥200 cells\u002FµL at screening.\n  2. Patients with HCV infection who have achieved sustained virologic response (SVR) at least 12 months before registration.\n\n     * Patients with Child-Pugh class A or B liver cirrhosis (Child-Pugh score 5-9).\n     * Patients who meet at least one of the following criteria for the diagnosis of liver cirrhosis:\n\n  \u003C!-- -->\n\n  1. Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.\n  2. Abdominal CT showing changes in liver morphology and\u002For findings suggestive of portal hypertension.\n\n     * Patients with an Eastern Cooperative Oncology Group Performance Status of 0-2.\n\nExclusion Criteria:\n\n* Patients with liver cirrhosis caused by etiologies other than HCV or of unknown etiology.\n* Patients with esophageal or gastric varices judged by endoscopic examination at screening to require treatment.\n* Patients with current malignancy or a history of malignancy within 3 years before registration.\n* Patients who have undergone liver transplantation or other organ transplantation, including bone marrow transplantation.\n* Patients with active AIDS-defining disease requiring treatment. -","MALE","18 Years","79 Years",{"count":97,"type":98},4,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","This is a phase 2 study designed to evaluate the efficacy and safety of foscenvivint in patients with liver cirrhosis resulting from HIV\u002FHCV co-infection in the setting of hemophilia.",[104],"Liver Cirrhosis",[104,106,107],"Hemophilia","HIV\u002FHCV co-infection","NOT_YET_RECRUITING","2026-06-26",{"date":111,"type":112},"2026-07-02","ACTUAL",{"date":114,"type":98},"2026-09-01",{"date":116,"type":98},"2028-03-31",{"name":21,"class":6},3]