[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645405":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":32,"responsibleParty":74,"collaborators":77,"id":84,"slug":11,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":106,"whyStopped":11,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"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",[33,51,66],{"facility":34,"status":11,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hokkaido University Hospital","Sapporo","Hokkaido","060-8648","Japan",{"type":40,"coordinates":41},"Point",[42,43],141.35,43.06667,{"lat":43,"lon":42},[46,50],{"name":47,"role":26,"phone":48,"phoneExt":11,"email":49},"Tomoyuki Endo, MD","+81-11-716-1161","t-endo@med.hokudai.ac.jp",{"name":47,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":52,"status":11,"city":53,"state":53,"zip":54,"country":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"National Hospital Organization Osaka National Hospital","Osaka","540-0006",{"type":40,"coordinates":56},[57,58],135.50107,34.69379,{"lat":58,"lon":57},[61,65],{"name":62,"role":26,"phone":63,"phoneExt":11,"email":64},"Ryotaro Sakamori, MD","+81-6-6942-1331","sakamori@gh.med.osaka-u.ac.jp",{"name":62,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":22,"status":11,"city":67,"state":68,"zip":69,"country":38,"cosmosGeoPoint":11,"geoPoint":11,"contacts":70},"Bunkyo-Ku","Tokyo","113-8677",[71,72,73],{"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":75,"investigatorFullName":21,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Head, Department of Hepatology",[78,81],{"name":79,"class":80},"Japan Agency for Medical Research and Development","OTHER_GOV",{"name":82,"class":83},"Ohara Pharmaceutical Co., Ltd.","INDUSTRY","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":95,"type":96},4,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102],"Liver Cirrhosis",[102,104,105],"Hemophilia","HIV\u002FHCV co-infection","NOT_YET_RECRUITING","2026-06-26",{"date":109,"type":110},"2026-07-02","ACTUAL",{"date":112,"type":96},"2026-09-01",{"date":114,"type":96},"2028-03-31",{"name":21,"class":6},3]