[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624169":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":51,"collaborators":53,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PCC treatment","EXPERIMENTAL",null,[13],"Drug: PCC",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","PCC","On-demand PCC therapy during bleeding episodes. The recommended dose was 50 IU\u002Fkg per infusion, administered every 8-12 hours, with a maximum total daily dose not exceeding 150 IU\u002Fkg.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Mankai Ju","CONTACT","+8615620988690","jumankai@ihcams.ac.cn",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Feng Xue","+862223608174","xuefeng@ihcams.ac.cn",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Institute of haematology and Blood diseases hospital","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":40,"coordinates":41},"Point",[42,43],117.17667,39.14222,{"lat":43,"lon":42},[46,47],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"name":48,"role":23,"phone":49,"phoneExt":11,"email":50},"Lei Zhang","2223608177","zhanglei1@ihcams.ac.cn",{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[54,56,58,60,62,65,67],{"name":55,"class":6},"North China University of Science and Technology",{"name":57,"class":6},"The Second Affiliated Hospital of Kunming Medical University",{"name":59,"class":6},"The Second People's Hospital of Anhui Province",{"name":61,"class":6},"Children's Hospital of Chongqing Medical University",{"name":63,"class":64},"Union Hospital, Affiliated to Fujian Medical University","UNKNOWN",{"name":66,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":68,"class":6},"First Affiliated Hospital of Guangxi Medical University","100624169","phase-4-pcc-treatment-for-hemophilia-patients-with-inhibitor2022pcc-a-100624169",false,"NCT07406139","PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）","A Multicenter, Prospective, Single-arm Exploratory Study of Prothrombin Complex Concentrate in the Treatment of Bleeding Episodes in Patients With Hemophilia A With Inhibitors","2022PCC-A","Inclusion Criteria:\n\n1. Diagnosed with hemophilia A with inhibitors. For high-responding patients (those who have previously had an inhibitor titer \\>5 BU), the inhibitor titer at enrollment must be \\>0.6 BU;\n2. Age between 12 and 65 years;\n3. At least three joint bleeding episodes within the past six months;\n4. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Presence of other congenital or acquired bleeding disorders;\n2. Liver function tests (ALT, AST) \\>2.5 times the upper limit of normal, or renal function tests (BUN, Cr) \\>1.5 times the upper limit of normal;\n3. Currently receiving immune tolerance induction (ITI) therapy with an inhibitor titer \\\u003C5 BU;\n4. History of thrombotic events;\n5. Known history of drug allergy, asthma, urticaria, or other allergic conditions;\n6. Deemed unsuitable for study participation by the investigator.","ALL","12 Years","65 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","This study is a multicenter, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of prothrombin complex concentrate (PCC) in the treatment of bleeding episodes in patients with hemophilia A with inhibitors. All participants received on-demand PCC therapy during bleeding episodes, with dosing adjusted by investigators according to the type of bleeding. The recommended dose was 50 IU\u002Fkg per infusion, administered every 8-12 hours, with a maximum total daily dose not exceeding 150 IU\u002Fkg. If no effective hemostasis was achieved within 24 hours, investigators could decide to add other hemostatic agents or switch to alternative treatments.",[88,89],"Hemophilia","Inhibitors","2026-02-09",{"date":92,"type":93},"2026-02-12","ACTUAL",{"date":95,"type":82},"2026-03-01",{"date":97,"type":82},"2026-12-20",{"name":5,"class":6},1]