[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100412787":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":68,"collaborators":19,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":19,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":19,"enrollmentInfo":79,"targetDuration":19,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"PharmaEssentia Japan K.K.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"P1101 (Ropeginterferon alfa-2b)","EXPERIMENTAL","Conventional treatment based on phlebotomies, lowdose aspirin (acetylsalicylic acid, 75-150 mg\u002Fday) plus the subcutaneous administration of pegylated prolineinterferon alpha-2b (P1101, Ropeginterferon alfa-2b) once every 2 weeks.",[13],"Biological: P1101 (Ropeginterferon alfa-2b)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","The subjects who have completed the 52-week treatment duration in Study A19-201 will be treated with P1101, starting at the dose at Week 50. The dose during this study may be increased or decreased up to 500 μg depending on the condition. This study will be continued as a post-marketing clinical study after acquisition of the marketing approval of P1101.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Keita Kirito, MD","University of Yamanashi Hospital","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Hiroaki Kawase","CONTACT","+81-3-6910-5103","hiroaki_kawase@pharmaessentia.com",[32,40,50,55,60,64],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Ehime University Hospital","RECRUITING","Toon-shi","Ehime","791-0295","Japan","JP",{"facility":41,"status":34,"city":42,"state":43,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":44,"geoPoint":49,"contacts":19},"Mie University Hospital","Tsu","Mie-ken",{"type":45,"coordinates":46},"Point",[47,48],136.51667,34.73333,{"lat":48,"lon":47},{"facility":51,"status":34,"city":52,"state":53,"zip":54,"country":38,"countryCode":39,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Osaka University Hospital","Suita-shi","Osaka","565-0871",{"facility":56,"status":34,"city":57,"state":58,"zip":59,"country":38,"countryCode":39,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Juntendo University Hospital","Bunkyo-ku","Tokyo","113-8431",{"facility":61,"status":34,"city":62,"state":58,"zip":63,"country":38,"countryCode":39,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Tokyo Medical University Hospital","Shinjuku-ku","160-0023",{"facility":23,"status":34,"city":65,"state":66,"zip":67,"country":38,"countryCode":39,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Chuo-shi","Yamanashi","409-3898",{"type":69,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100412787","phase-3-extension-study-of-p1101-after-completion-of-phase-2-study-in-pv-patients-or-phase-3-study-in-et-patients-100412787",false,"NCT04655092","Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients","Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)","Inclusion Criteria:\n\n* Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study\n* Patients who have given written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101","ALL","20 Years",{"count":80,"type":81},67,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.",[87],"Polycythemia Vera (PV)",[89],"Myeloproliferative Neoplasms","2024-11-06",{"date":92,"type":93},"2024-11-08","ACTUAL",{"date":95,"type":93},"2021-01-19",{"date":97,"type":81},"2026-06-30",{"name":5,"class":6},6]