[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608023":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":35,"responsibleParty":49,"collaborators":30,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":30,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":30,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":30,"overallStatus":73,"whyStopped":30,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Golidocitinib Part B","EXPERIMENTAL","Golidocitinib at recommended phase 2 doses, administered orally, once daily.",[13],"Drug: Golidocitinib",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Part B","PLACEBO_COMPARATOR","Placebo at recommended phase 2 doses, administered orally, once daily.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Golidocitinib Part A","Golidocitinib dose escalation, administered orally, once daily.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Golidocitinib","Golidocitinib will be administered orally as capsules in a 28-day cycle.",[21,9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Placebo","Placebo will be administered orally as capsules in a 28-day cycle.",[15],[36],{"facility":37,"status":30,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":30},"Peking University Insititute of Hematology, Peking University People's Hospital","Beijing","Beijing Municipality","100010","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Xiao Hui Zhang","Associate Director","100608023","phase-1-an-exploratory-study-of-golidocitinib-in-adult-patients-with-itp-100608023",false,"NCT07196163","An Exploratory Study of Golidocitinib in Adult Patients With ITP","An Exploratory Clinical Study of Golidocitinib in Adult Patients With Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n* Male and female participants between 18 and 80 years old.\n* Primary ITP for \\>3 months.\n* An average of two platelet counts (⩾ 7 days apart) of \\\u003C 30 × 10⁹\u002FL.\n* Have relapsed or treatment-resistant to previous ITP therapies, including corticosteroids and at least one other ITP therapy.\n* Have history of response to previous treatments.\n* Adequate hematologic, hepatic, and renal fuction.\n* Participants willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\n* Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia.\n* Previous or current therapy and comedications meet exclusion criteria.\n* Patients with major caridiovascular disease, active infetion, maligancy or uncontrolled systemic disease.\n* Women who are breast feeding.\n* History of hypersensitivity to sudy drug with a similar chemical structure or class.\n* Previously received JAK inhibitors.","ALL","18 Years","80 Years",{"count":64,"type":65},138,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE1","PHASE2","This is a multicenter clinical study to evaluate the safety and efficacy of golidocitinib in patients with primary immune thrombocytopenia (ITP). The study consists of two parts: Part A dose escalation and Part B dose expansion. Part A is designed to obtain the safety profile of golidocitinib in patients with ITP and the recommended dose for the randomized cohort in Part B. Part B is a randomized, double-blind, placebo-controlled study, and the primary objective of this part is to evaluate the preliminary efficacy of golidocitinib in patients with ITP.",[72],"Immune Thrombocytopenia (ITP)","NOT_YET_RECRUITING","2025-09-19",{"date":76,"type":77},"2025-09-29","ACTUAL",{"date":79,"type":65},"2025-10-30",{"date":81,"type":65},"2029-10-30",{"name":5,"class":6},1]