[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558539":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":145,"collaborators":11,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":11,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":11,"enrollmentInfo":156,"targetDuration":11,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Xiamen Amoytop Biotech Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Peginterferon α-2b 135 mcg dose group","EXPERIMENTAL",null,[13],"Drug: Peginterferon α-2b injection",{"label":15,"type":10,"description":11,"interventionNames":16},"Peginterferon α-2b 180 mcg dose group",[13],[18,23],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Peginterferon α-2b injection","Peginterferon α-2b injection, 135 mcg, s.c., once a week, during the targeted treatment period (the first 48 week), peginterferon α-2b dose is depended on the patient's response and tolerability during the extension treatment (week 49 to week 96).",[9],{"type":19,"name":20,"description":24,"armGroupLabels":25,"otherNames":11},"Peginterferon α-2b injection, 180 mcg, s.c., once a week, during the targeted treatment period (the first 48 week), peginterferon α-2b dose is depended on the patient's response and tolerability during the extension treatment (week 49 to week 96).",[15],[27],{"name":28,"affiliation":29,"role":30},"Lei Zhang","Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":11,"email":35},"CONTACT","13502118379","zhanglei1@ihcams.ac.cn",{"name":37,"role":33,"phone":34,"phoneExt":11,"email":38},"Rongfeng Fu","furongfeng@ihcams.ac.cn",[40,57,67,80,93,106,119,132],{"facility":41,"status":42,"city":43,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Peking Union Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":55,"phoneExt":11,"email":56},"Minghui Duan","13621262462","mhduan@sina.com",{"facility":58,"status":42,"city":43,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Peking University People's Hospital",{"type":47,"coordinates":60},[49,50],{"lat":50,"lon":49},[63],{"name":64,"role":33,"phone":65,"phoneExt":11,"email":66},"Hongxia Shi","13661049635","hxshi55@sina.com",{"facility":68,"status":42,"city":69,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Union Hospital affiliated to Fujian Medical University","Fujian",{"type":47,"coordinates":71},[72,73],106.12972,28.92651,{"lat":73,"lon":72},[76],{"name":77,"role":33,"phone":78,"phoneExt":11,"email":79},"Yong Wu","13365910911","wuyong9195@126.com",{"facility":81,"status":42,"city":82,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Nanfang Hospital, Southern Medical University","Guangzhou",{"type":47,"coordinates":84},[85,86],113.25,23.11667,{"lat":86,"lon":85},[89],{"name":90,"role":33,"phone":91,"phoneExt":11,"email":92},"Na Xu","18620698390","sprenaa@163.com",{"facility":94,"status":42,"city":95,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Harbin First Hospital","Harbin",{"type":47,"coordinates":97},[98,99],126.65,45.75,{"lat":99,"lon":98},[102],{"name":103,"role":33,"phone":104,"phoneExt":11,"email":105},"Tiejun Gong","13836027737","arac@sina.com",{"facility":107,"status":42,"city":108,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Henan Cancer Hospital","Henan",{"type":47,"coordinates":110},[111,112],112.22494,37.92189,{"lat":112,"lon":111},[115],{"name":116,"role":33,"phone":117,"phoneExt":11,"email":118},"Hu Zhou","13939068863","tigerzhoupumc@163.com",{"facility":120,"status":42,"city":121,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai",{"type":47,"coordinates":123},[124,125],121.45806,31.22222,{"lat":125,"lon":124},[128],{"name":129,"role":33,"phone":130,"phoneExt":11,"email":131},"Wen Wu","13611770009","ww10649@rjh.com.cn",{"facility":133,"status":42,"city":134,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"The First Affiliated Hospital of Zhejiang University School of Medicine","Zhejiang",{"type":47,"coordinates":136},[137,138],105.583,25.3238,{"lat":138,"lon":137},[141],{"name":142,"role":33,"phone":143,"phoneExt":11,"email":144},"Hongyan Tong","13958122357","hongyantong@aliyun.com",{"type":146,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100558539","phase-2-peginterferon--2b-injection-for-hydroxyurea-resistant-or-intolerant-et-100558539",false,"NCT06552429","Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET","A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea.","Inclusion Criteria:\n\n* Male or female subjects, aged greater or equal to 18 years old at screening;\n* Subjects diagnosed as high-risk ET according to the World Health Organization (WHO) 2016 criteria：1) who is older than 60 years and JAK2V617F positive at screening, 2) or who previously suffered from disease-related thrombosis or hemorrhage;\n* Subjects who have previously received HU for ET, and the time interval between the last HU dose and the first dose of the study drug should not be less than 7 days;\n* Interferon treatment-naïve, and for those who have previously received interferon the the time interval between the last dose of interferon and randomization should not be less than 1 month;\n* Patients with confirmed hydroxyurea resistance or intolerant, as at least one of the following criteria is met:\n\n  1. Platelet count remain greater than 600×10\\^9 \u002FL after at least 3 months of HU treatment at a dose ≥2g\u002Fd (dose ≥2.5 g\u002Fd if subject weight \\> 80 kg);\n  2. Platelet count greater than 400\\*10\\^9\u002FL while white blood cell (WBC) count lower than 2.5\\*10\\^9\u002FL, or platelet count greater than 400\\*10\\^9 \u002FL while hemoglobin lower than 100 g\u002FL at any dose of HU;\n  3. Presence of HU-related toxicities at any dose of HU: e.g. ulcers in legs, or any unacceptable skin mucosal manifestations or fever;\n* Platelet counts \\> 450\\*10\\^9\u002FL at screening;\n* Neutrophil count ≥1.0\\*10\\^9\u002FL at screening;\n* Haemoglobin ≥11 g\u002FdL at screening for males and 10 g\u002FdL for females at screening;\n* There is no serious function damage in liver and kidney: total bilirubin ≤1.5 upper limit of normal (ULN), alanine aminotransferase≤2.0 ULN, aspartate aminotransferase≤2.0 ULN, prothrombin time is prolonged by less than 4 seconds, Creatinine clearance ≥50 mL\u002Fmin (according to Cockcroft-Gault formula) at screening;\n* Both male and female subjects must agree take an appropriate contraceptive method, including:\n\n  1. Male subjects: must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug.\n  2. Female subjects: Must meet at least one of the following conditions:\n\n  i) Women without childbearing potential; ii) Women of childbearing potential: no pregnant or breastfeed, negative in blood pregnancy test within 4 days prior to the first dosing, and must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug;\n* Subjects understand the objective, characteristic, method and possible adverse reactions of the study, voluntarily participate in this study, and sign informed consent.\n\nExclusion Criteria:\n\n* History of any other myeloproliferative tumors, or evidence of the presence of any other myeloproliferative tumors;\n* Contraindications or hypersensitivities to interferons of any of its excipients;\n* Severe medical conditions or serious comorbidities that the investigators determined could jeopardize the safety or protocol adherence, e.g. New York Heart Association \\[NYHA\\] Class III-IV, congestive heart failure, symptomatic arrhythmias，pulmonary hypertension;\n* History of major organ transplantation;\n* Documented autoimmune disease or history of autoimmune disease at screening, e.g. medication un-controlled thyroid dysfunction, autoimmune hepatitis, idiopathic thrombocytopenic purpura, scleroderma, psoriasis, or any autoimmune arthritis;\n* Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia at screening that, in the investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol;\n* Infection with systemic clinical manifestations at screening, e.g., bacteria, fungi, human immunodeficiency virus, excluding hepatitis B and\u002For C;\n* Evidence of severe retinopathy, e.g., cytomegalovirus retinitis, symptomatic macular degeneration, or clinically significant eye disease, e.g. due to diabetes mellitus or hypertension;\n* Diagnosed clinically significant depression or a history of depression and, in the investigator's opinion, previous suicide attempts or at any risk of suicide at screening;\n* Diagnosed clinically significant neurological disease or a history of clinically significant neurological disease, except for a history of stable cerebral thrombosis or cerebral hemorrhage;\n* History of any malignancy within 5 years (except stage 0 chronic lymphocytic leukemia, basal cell carcinoma, squamous cell carcinoma, and superficial melanoma);\n* A history of alcohol or drug abuse within 1 year;\n* Have used any investigational drug within 4 weeks prior to first dose of investigational drug, or not recovered from the effects of prior investigational drug administration;\n* Other situations that, in the investigator's opinion, not appropriate for inclusion.","ALL","18 Years",{"count":157,"type":158},27,"ESTIMATED","INTERVENTIONAL",[161],"PHASE2","This is a multicenter, randomized, open-label Phase 2 clinical study. It is aimed to enroll 27 essential thrombocytopenia (ET) patients who are resistant to or intolerant of hydroxyurea(HU). Eligible patients will be randomized to receive either Peginterferon α-2b 135 mcg or Peginterferon α-2b 180 mcg at a ratio of 1:2, and all subjects will go through a target treatment period (Weeks 1 \\~ Week 48), an extension treatment period (Weeks 49 \\~ Week 96) and a follow-up period (Weeks 97 \\~ Week 100). Pharmacokinetics, safety, efficacy will be evaluated.",[164],"Essential Thrombocythemia",[164,166,167,168],"Peginterferon α-2b","hydroxyurea resistant","hydroxyurea intolerant","2025-11-13",{"date":171,"type":172},"2025-11-17","ACTUAL",{"date":174,"type":172},"2024-08-29",{"date":176,"type":158},"2027-09",{"name":5,"class":6},8]