[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635341":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":369,"collaborators":20,"id":371,"slug":20,"hasResults":372,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":20,"eligibilityCriteria":376,"healthyVolunteers":372,"sex":377,"minAge":378,"maxAge":20,"enrollmentInfo":379,"targetDuration":20,"studyType":382,"phases":383,"briefSummary":385,"conditions":386,"keywords":20,"overallStatus":388,"whyStopped":20,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":398},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TQ05105 Tablets","EXPERIMENTAL","TQ05105 Tablets, 28 days as a treatment cycle.",[13],"Drug: TQ05105 Tablets (Rovadicitinib Tablets)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TQ05105 Tablets (Rovadicitinib Tablets)","TQ05105 is an inhibitor of Janus kinase 1 (JAK1), Janus kinase 2 (JAK2), and Rho-associated coiled-coil containing protein kinase 1 (ROCK1) and 2 (ROCK2).",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Chunkang Chang, Doctor","CONTACT","13764643870","changchunkang7010@aliyun.com",[28,41,56,71,86,101,115,129,143,158,173,183,198,213,227,242,257,272,282,294,309,324,339,354],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":20},"The First Affiliated Hospital of University of Science and Technology of China","Hefei","Anhui","230001","China","CN",{"type":36,"coordinates":37},"Point",[38,39],117.28083,31.86389,{"lat":39,"lon":38},{"facility":42,"status":20,"city":43,"state":44,"zip":45,"country":33,"countryCode":34,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"Fujian Medical University Union Hospital","Fuzhou","Fujian","350001",{"type":36,"coordinates":47},[48,49],119.30611,26.06139,{"lat":49,"lon":48},[52],{"name":53,"role":24,"phone":54,"phoneExt":20,"email":55},"Yong Wu, Doctor","13365910911","wuyong9195@126.com",{"facility":57,"status":20,"city":58,"state":59,"zip":60,"country":33,"countryCode":34,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Guangzhou First Municipal People's Hospital","Guangzhou","Guangdong","510180",{"type":36,"coordinates":62},[63,64],113.25,23.11667,{"lat":64,"lon":63},[67],{"name":68,"role":24,"phone":69,"phoneExt":20,"email":70},"Shunqing Wang, Doctor","13437807998","drwangshq@medmail.com.cn",{"facility":72,"status":20,"city":73,"state":74,"zip":75,"country":33,"countryCode":34,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","530000",{"type":36,"coordinates":77},[78,79],108.31667,22.81667,{"lat":79,"lon":78},[82],{"name":83,"role":24,"phone":84,"phoneExt":20,"email":85},"Zhenfang Liu, Doctor","13481082237","liuliuzhenfang@163.com",{"facility":87,"status":20,"city":88,"state":89,"zip":90,"country":33,"countryCode":34,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Cangzhou People's Hospital rovince","Cangzhou","Hebei","061014",{"type":36,"coordinates":92},[93,94],116.85334,38.31124,{"lat":94,"lon":93},[97],{"name":98,"role":24,"phone":99,"phoneExt":20,"email":100},"Hongmei Ma, Master","18031798229","mhm-sspc@163.com",{"facility":102,"status":20,"city":103,"state":89,"zip":104,"country":33,"countryCode":34,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Affiliated Hospital of Chengde Medical College","Chengde","067000",{"type":36,"coordinates":106},[107,108],117.95883,40.9519,{"lat":108,"lon":107},[111],{"name":112,"role":24,"phone":113,"phoneExt":20,"email":114},"Zhihua Zhang, Master","15633142905","zzhangzhihua@163.com",{"facility":116,"status":20,"city":117,"state":89,"zip":118,"country":33,"countryCode":34,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"The Second Hospital of Hebei Medical University","Shijiazhuang","050000",{"type":36,"coordinates":120},[121,122],114.47861,38.04139,{"lat":122,"lon":121},[125],{"name":126,"role":24,"phone":127,"phoneExt":20,"email":128},"Xuejun Zhang, Doctor","13722781112","zhxjhbmu@126.com",{"facility":130,"status":20,"city":131,"state":89,"zip":132,"country":33,"countryCode":34,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Xingtai People's Hospital","Xingtai","054000",{"type":36,"coordinates":134},[135,136],114.49272,37.06217,{"lat":136,"lon":135},[139],{"name":140,"role":24,"phone":141,"phoneExt":20,"email":142},"Zongjiu Jiao, Master","18631921299","1449569258@qq.com",{"facility":144,"status":20,"city":145,"state":146,"zip":147,"country":33,"countryCode":34,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Henan Cancer Hospital","Zhengzhou","Henan","450000",{"type":36,"coordinates":149},[150,151],113.64861,34.75778,{"lat":151,"lon":150},[154],{"name":155,"role":24,"phone":156,"phoneExt":20,"email":157},"Hu Zhou, Doctor","13939068863","papertigerhu@163.com",{"facility":159,"status":20,"city":160,"state":161,"zip":162,"country":33,"countryCode":34,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology","Wuhan","Hubei","430071",{"type":36,"coordinates":164},[165,166],114.26667,30.58333,{"lat":166,"lon":165},[169],{"name":170,"role":24,"phone":171,"phoneExt":20,"email":172},"Zhenya Hong, Postdoctoral","13476158466","hongzhenya@sina.com",{"facility":174,"status":20,"city":160,"state":161,"zip":162,"country":33,"countryCode":34,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"Union Hospital Tongji College Huazhong University of Science and Technology",{"type":36,"coordinates":176},[165,166],{"lat":166,"lon":165},[179],{"name":180,"role":24,"phone":181,"phoneExt":20,"email":182},"Min Zhang, Doctor","15871818568","Zhangmin35@aliyun.com",{"facility":184,"status":20,"city":185,"state":186,"zip":187,"country":33,"countryCode":34,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Zhuzhou Central Hospital","Zhuzhou","Hunan","412000",{"type":36,"coordinates":189},[190,191],113.15,27.83333,{"lat":191,"lon":190},[194],{"name":195,"role":24,"phone":196,"phoneExt":20,"email":197},"Chanjuan Shen, Master","18973389928","shenchanjuan@163.com",{"facility":199,"status":20,"city":200,"state":201,"zip":202,"country":33,"countryCode":34,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Nanjing Drum Tower Hospital","Nanjin","Jiangsu","210000",{"type":36,"coordinates":204},[205,206],121.74055,31.75772,{"lat":206,"lon":205},[209],{"name":210,"role":24,"phone":211,"phoneExt":20,"email":212},"Bing Chen, Doctor","13951806490","chenbinggcp@163.com",{"facility":214,"status":20,"city":215,"state":201,"zip":216,"country":33,"countryCode":34,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Jiangsu Provincial Hospital of Traditional Chinese Medicine","Nanjing","210029",{"type":36,"coordinates":218},[219,220],118.77778,32.06167,{"lat":220,"lon":219},[223],{"name":224,"role":24,"phone":225,"phoneExt":20,"email":226},"Xuejun Zhu, Doctor","13505152806","zhuxj2@sina.com",{"facility":228,"status":20,"city":229,"state":230,"zip":231,"country":33,"countryCode":34,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"The First Hospital of Jilin University","Changchun","Jilin","130021",{"type":36,"coordinates":233},[234,235],125.32278,43.88,{"lat":235,"lon":234},[238],{"name":239,"role":24,"phone":240,"phoneExt":20,"email":241},"Sujun Gao, Doctor","15843073208","sujung1963@163.com",{"facility":243,"status":20,"city":244,"state":245,"zip":246,"country":33,"countryCode":34,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Shengjing Hospital Affiliated to China Medical University","Shenyang","Liaoning","110000",{"type":36,"coordinates":248},[249,250],123.43278,41.79222,{"lat":250,"lon":249},[253],{"name":254,"role":24,"phone":255,"phoneExt":20,"email":256},"Huihan Wang, Doctor","18940256966","wanghh@sj-hospital.org",{"facility":258,"status":20,"city":259,"state":260,"zip":261,"country":33,"countryCode":34,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"The First Affiliated Hospital of Air Force Medical University","Xi'an","Shaanxi","710000",{"type":36,"coordinates":263},[264,265],108.92861,34.25833,{"lat":265,"lon":264},[268],{"name":269,"role":24,"phone":270,"phoneExt":20,"email":271},"Guangxun Gao, Doctor","13991907320","gaoguangxun@fmmu.edu.cn",{"facility":273,"status":20,"city":259,"state":260,"zip":261,"country":33,"countryCode":34,"cosmosGeoPoint":274,"geoPoint":276,"contacts":277},"The First Affiliated Hospital of Xi'an Jiaotong University",{"type":36,"coordinates":275},[264,265],{"lat":265,"lon":264},[278],{"name":279,"role":24,"phone":280,"phoneExt":20,"email":281},"Pengcheng He, Doctor","18991232609","hpec_gcp@163.com",{"facility":283,"status":20,"city":284,"state":285,"zip":286,"country":33,"countryCode":34,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"Shanghai Sixth People's Hospital","Shanghai","Shanghai Municipality","200233",{"type":36,"coordinates":288},[289,290],121.45806,31.22222,{"lat":290,"lon":289},[293],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"facility":295,"status":20,"city":296,"state":297,"zip":298,"country":33,"countryCode":34,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Heping Hospital Affiliated To Changzhi Medical College","Changzhi","Shanxi","046000",{"type":36,"coordinates":300},[301,302],113.10528,36.18389,{"lat":302,"lon":301},[305],{"name":306,"role":24,"phone":307,"phoneExt":20,"email":308},"Xuliang Shen, Doctor","13015365546","shenxlcyp@sohu.com",{"facility":310,"status":20,"city":311,"state":312,"zip":313,"country":33,"countryCode":34,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"Sichuan Provincial People's Hospital","Chengdu","Sichuan","610000",{"type":36,"coordinates":315},[316,317],104.06667,30.66667,{"lat":317,"lon":316},[320],{"name":321,"role":24,"phone":322,"phoneExt":20,"email":323},"Xiaobing Huang, Doctor","18981838236","hxb_trial@163.com",{"facility":325,"status":20,"city":326,"state":327,"zip":328,"country":33,"countryCode":34,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Chinese Academy of Medical Sciences Hematology Hospital","Tianjin","Tianjin Municipality","301617",{"type":36,"coordinates":330},[331,332],117.17667,39.14222,{"lat":332,"lon":331},[335],{"name":336,"role":24,"phone":337,"phoneExt":20,"email":338},"Bo Jiang, Doctor","18630810181","jiangbo@ihcams.as.cn",{"facility":340,"status":20,"city":341,"state":342,"zip":343,"country":33,"countryCode":34,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"The First Affiliated Hospital of Xinjiang Medical University","Ürümqi","Xinjiang","830011",{"type":36,"coordinates":345},[346,347],87.60046,43.80096,{"lat":347,"lon":346},[350],{"name":351,"role":24,"phone":352,"phoneExt":20,"email":353},"Jianping Hao, Master","13579876416","13579876416@163.com",{"facility":355,"status":20,"city":356,"state":357,"zip":358,"country":33,"countryCode":34,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":36,"coordinates":360},[361,362],120.16142,30.29365,{"lat":362,"lon":361},[365],{"name":366,"role":24,"phone":367,"phoneExt":20,"email":368},"Hongyan Tong, Doctor","13958122357","hongyantong@aliyun.com",{"type":370,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100635341",false,"NCT07551427","A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate\u002FHigh-risk Myelofibrosis","A Phase II, Single-arm, Open-label, Multicenter Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate\u002FHigh-risk Myelofibrosis","Inclusion Criteria:\n\n1. Voluntary and signed informed consent, good compliance.\n2. Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.\n3. Diagnosis of primary myelofibrosis (PMF) per World Health Organization (WHO) 2016, or post-polycythemia vera myelofibrosis (post-PV-MF) or post-essential thrombocythemia myelofibrosis (post-ET-MF) per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria; Janus kinase 2 (JAK2) mutation status not restricted.\n4. Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).\n5. Cohort 1: Renal function classified as normal, mild impairment, or moderate impairment. Cohort 2: Prior Janus kinase (JAK) inhibitor therapy with refractory, relapsed, or intolerant.\n6. Spleen enlargement (except Cohort 1).\n7. Peripheral blood and bone marrow blasts ≤10%.\n8. No growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks before first dose; and routine blood parameters meet requirements within 7 days before first dose.\n9. Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1).\n10. Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating.\n\nExclusion Criteria:\n\n1. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.\n2. Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).\n3. Prior splenectomy or splenic radiotherapy within 6 months before first dose.\n4. Other malignancies within 3 years before first dose or currently present (exceptions per protocol).\n5. Factors affecting oral drug absorption.\n6. Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).\n7. Major surgery or significant traumatic injury within 4 weeks before first dose.\n8. Congenital bleeding or coagulation disorders.\n9. Arterial\u002Fvenous thrombosis event within 6 months before first dose.\n10. History of substance abuse or mental disorder.\n11. Active or uncontrolled severe infection.\n12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n13. Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure.\n14. Uncontrolled hypertension despite standard therapy.\n15. Renal failure requiring hemodialysis or peritoneal dialysis.\n16. Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose.\n17. History of immunodeficiency or organ transplantation.\n18. Epilepsy requiring treatment.\n19. Use of protocol-prohibited myelofibrosis (MF) medications, immunomodulators, or immunosuppressants within specified time before first dose.\n20. Use of Chinese patent medicines with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before first dose.\n21. Uncontrolled pleural effusion, pericardial effusion, or ascites.\n22. Live attenuated vaccine within 4 weeks before first dose or planned during the study.\n23. Known hypersensitivity to study drug or excipients.\n24. Diagnosis of active autoimmune disease within 2 years before first dose.\n25. Participation in another interventional clinical trial with investigational drug within 4 weeks before first dose.\n26. Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.","ALL","18 Years",{"count":380,"type":381},51,"ESTIMATED","INTERVENTIONAL",[384],"PHASE2","This is an open-label, single-arm, multi-center phase II study consisting of two cohorts. Cohort 1 evaluates the pharmacokinetics (PK) of TQ05105 in myelofibrosis participants with normal, mild, or moderate renal impairment to guide dosing. Cohort 2 evaluates the efficacy and safety of TQ05105 in participants with intermediate\u002Fhigh-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.",[387],"Myelofibrosis","NOT_YET_RECRUITING","2026-04-22",{"date":391,"type":392},"2026-04-24","ACTUAL",{"date":394,"type":381},"2026-05",{"date":396,"type":381},"2029-06",{"name":5,"class":6},24]