[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623716":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":50,"collaborators":21,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":21,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":21,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Orelabrutinib combined with Romiplostim N01","EXPERIMENTAL","The experimental arm will be treated orelabrutinib plus romiplostim N01. The study consists of three phases: 1) Core Treatment Phase (Weeks 1-24): Orelabrutinib 50mg orally once daily (fixed dose) + romiplostim N01 subcutaneously (starting dose 3ug\u002Fkg\u002Fweek, administered once weekly). Platelet count and clinical symptoms are assessed weekly to adjust the dose of romiplostim N01 as appropriate, with a maximum dose of 10ug\u002Fkg\u002Fweek. Patients with platelet count (PLT) \\\u003C50×10⁹\u002FL after 28 days of maximum-dose romiplostim N01 withdraw. 2) Tapering Phase (Weeks 25-32): Eligible patients (PLT ≥50×10⁹\u002FL in the last two core phase visits) discontinue orelabrutinib, then taper romiplostim N01 (dose reduction + extended intervals); patients with two consecutive PLT \\\u003C30×10⁹\u002FL withdraw. 3) Follow-up Phase (Weeks 33-56): Successfully tapered patients are followed up every 4 weeks to monitor PLT and adverse events (graded per NCI-CTC AE 5.0).",[13,14],"Drug: Orelabrutinib","Drug: Romiplostim N01",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Orelabrutinib","Orelabrutinib will be given as 50mg per day orally, week 1-24",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Romiplostim N01","Core Treatment Phase Recommended starting dose: 3 μg\u002Fkg subcutaneously once weekly. Monitor platelet count (PLT) and symptoms weekly for dose adjustment, max 10 μg\u002Fkg\u002Fweek. Therapeutic target: Maintain PLT within the range of 50-200×10⁹\u002FL.\n\n1. PLT \\\u003C 50×10⁹\u002FL: Increase by 1-3 μg\u002Fkg\u002Fweek to max dose. Discontinue study if PLT remains \\\u003C 50×10⁹\u002FL after 28d of max dose.\n2. 50-200×10⁹\u002FL: Maintain the minimum effective dose to reduce bleeding risk.\n3. 200-400×10⁹\u002FL: Decrease by 1-3 μg\u002Fkg\u002Fweek. Discontinue if PLT ≥200×10⁹\u002FL at 250 μg\u002Fweek; resume when PLT \\\u003C50×10⁹\u002FL (extend interval if needed).\n4. PLT \\>400×10⁹\u002FL: Suspend; resume at 1-3 μg\u002Fkg lower dose when PLT \\\u003C200×10⁹\u002FL (weekly monitoring).\n\nTapering Phase For maintenance dose \\>3 μg\u002Fkg\u002Fweek: Taper by 1-3 μg\u002Fkg\u002Fweek to ≤3 μg\u002Fkg (250 μg\u002Fweek), then extend intervals (weekly→every 10 days→every 2 weeks).\n\n1. PLT \\\u003C30×10⁹\u002FL: Maintain current dose.\n2. Two consecutive PLT \\\u003C30×10⁹\u002FL: Discontinue study.",[9],[27],{"name":28,"affiliation":5,"role":29},"Tienan Zhu, M.D.","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},"CONTACT","010-69155027","zhutn@pumch.cn",[36],{"facility":5,"status":21,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Beijing","Beijing Municipality","100010","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},{"type":51,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100623716","phase-2-phase-ii-study-of-orelabrutinib-in-combination-with-romiplostim-n01-in-patients-with-primary-immune-thrombocytopenia-itp-who-have-received-at-least-one-prior-line-of-therapy-100623716",false,"NCT07400250","Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy","Phase II Study of Orelabrutinib in Combination With Romiplostim in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received at Least One Prior Line of Therapy","ORBIT","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study and provide written informed consent；\n2. Age 18-80 years, inclusive, regardless of gender；\n3. ECOG score 0 to 2；\n4. Documented diagnosis of chronic primary Immune Thrombocytopenia (ITP) with a disease duration \\>12 months；\n5. Patients with an inadequate sustained response, relapse, intolerance, or insufficient response to first-line ITP therapy (corticosteroids and\u002For intravenous immunoglobulin). Prior receipt of other ITP treatments is allowed, with no limit on the number of prior lines；\n6. A history of response to prior standard ITP therapy (defined as achieving a platelet count ≥50×10⁹\u002FL)；\n7. During or following the most recent ITP treatment, patients must have experienced either: treatment failure (platelet count \\\u003C30×10⁹\u002FL after treatment, or failure to double the baseline count, or occurrence of bleeding), relapse after initial response (platelet count decreased to \\\u003C30×10⁹\u002FL, or fell below twice the baseline, or bleeding symptoms recurred), treatment intolerance, or an inability to maintain response after treatment discontinuation；\n8. Subjects demonstrate adequate comprehension of and are able to comply with the study protocol requirements, and are willing to complete the study according to the schedule.\n\nExclusion Criteria:\n\n1. Subjects suffer from severe ITP at screening;\n2. Subjects have other diseases which mention in protocol;\n3. Subjects develop intracranial hemorrhage within 6 months prior to screening;\n4. Active and uncontrollable infection;\n\n6\\. Subjects have a history of coagulopathy other than ITP; 7. Subjects with a history of malignancies; 8. History of major organ transplantation or hematopoietic stem cell\u002Fbone marrow transplantation; 9. Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients; 10. Subjects with a Medication history and surgical history which mention in protocol; 11. Subjects do not meet the criterion of the laboratory test in protocol.\n\nWithdrawal Criteria:\n\n1. If, after 4 consecutive weeks of Romiplostim N01 administration at the maximum dose (10 µg\u002Fkg once weekly), the platelet count remains \\\u003C50×10⁹\u002FL and the investigator judges the investigational product to be ineffective for the subject, such that continued use is not in the subject's best interest；\n2. Subjects who are unable to successfully undergo treatment tapering or discontinuation；\n3. Subjects who, during the treatment period, require rescue therapy based on clinical assessment；\n4. Subjects who withdraw their informed consent.\n5. Occurrence of pregnancy during the trial period\n6. Poor subject compliance or a significant protocol violation；\n7. Loss to follow-up；\n8. The investigator decides that withdrawal is necessary for the subject's safety；\n9. Presence of other conditions, as determined by the investigator, that may affect the study results or lead to premature termination of the study；\n10. Study completion or early termination of the entire study.","ALL","18 Years","80 Years",{"count":64,"type":65},28,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","To evaluate whether orelabrutinib combined with romiplostim N01 can improve the quality of remission, increase the probability of successful drug withdrawal, and prolong the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who have received at least one line of prior therapy.",[71],"Primary Immune Thrombocytopenia (ITP)",[73,74,75],"primary immune thrombocytopenia","orelabrutinib","romiplostim N01","NOT_YET_RECRUITING","2026-02-03",{"date":79,"type":80},"2026-02-10","ACTUAL",{"date":82,"type":65},"2026-04-01",{"date":84,"type":65},"2028-10-01",{"name":5,"class":6},1]