[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-immune-thrombocytopenia-itp\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-immune-thrombocytopenia-itp":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,49,78,106,130,156,178,202,228,254,276,301,328,349,373,401],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100625325","phase-2-a-study-to-assess-the-tolerability-of-ianalumab-vay736-with-investigators-choice-thrombopoietin-receptor-agonist-ic-tpo-ra-in-patients-with-primary-immune-thrombocytopenia-itp-100625325",false,"NCT07421167","A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)","A Phase 2 Open-label Study to Evaluate the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least One Treatment (VAY2EXPLORE)","VAY2EXPLORE","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Patients aged 18 years and older on the day of signing the informed consent.\n* ITP cohort only: Confirmed diagnosis of primary ITP that has previously responded to corticosteroid treatment or IVIG treatment but the response was not sustained (response is defined as a platelet count ≥ 50 G\u002FL).\n* ITP cohort only: Received at least one prior treatment for ITP.\n* ITP cohort only: Patients with a platelet count \\\u003C 100 G\u002FL who are receiving a TPO-RA. Patients may already be receiving a TPO-RA or may start a TPO-RA at the time of screening. All patients should be on a stable dose of TPO-RA for at least 14 days prior to first dose of ianalumab. Note: during the screening period, a documented assessment of platelets \\\u003C 100 G\u002FL is mandatory for enrollment. For patients who received rescue medication before screening, platelet count results obtained prior to the start of the rescue therapy should be used to assess eligibility if collected within 14 days prior to screening.\n* ES cohort only: Patients with clinical diagnosis of primary ES with active thrombocytopenia (\\\u003C 100 G\u002FL) with warm autoimmune hemolytic anemia (wAIHA) for whom a TPO-RA is appropriate per Investigator.\n* ES cohort only: Inadequate response to or relapse after treatment with corticosteroid therapy.\n* ES cohort only: Diagnosis confirmed by current or past positive direct antiglobulin test (DAT) (IgG+, with or without C3+) and evidence of hemolysis.\n* ES cohort only: any supportive care treatment administered for wAIHA must be stable for at least 4 weeks prior to enrollment.\n\nKey Exclusion Criteria:\n\n* Patients being treated with TPO-RA for \\> 6 months.\n* Current life-threatening bleeding (related to thrombocytopenia).\n* Prior splenectomy within 6 months of first administration of ianalumab.\n* Patients with the following laboratory abnormalities:\n\n  * Neutrophils: \\\u003C 1000\u002Fmm3\n  * Serum creatinine \\> 1.5 × upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) \\> 3.0 × ULN\n  * Alanine aminotransferase (ALT) \\> 3.0 × ULN\n  * Immunoglobulin G (IgG) \\\u003C 5 g\u002FL\n  * ITP cohort only: hemoglobin \\\u003C 10 g\u002FL, total bilirubin \\> 1.5 × ULN\n* Patients with significantly compromised liver disease (Child-Pugh 7 to 9) and decompensated liver disease (Child-Pugh 10 to 15).\n* Treatment with a B-cell depleting therapy (e.g. rituximab or anti-B cell Activating Factor (e.g. belimumab) within 12 weeks prior to the first administration of ianalumab. Patients who are refractory to rituximab will be excluded from this trial, where refractory is defined as:\n\n  \\~ Patients who have not achieved a response (defined as platelet count ≥ 30 G\u002FL and at least doubling from baseline within 12 weeks in the absence of rescue therapy) following completion of a standard course of rituximab\n* History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.\n* Known history of primary or secondary immunodeficiency, or a positive human immunodeficiency virus (HIV) enzyme-linked immunosorbent assay (ELISA) and Western blot) test result.\n* Patients exposed to more than 4 prior treatments for ITP.\n* ITP cohort only: Diagnosis of secondary thrombocytopenia.\n* ITP cohort: Use of immunosuppressant drugs other than corticosteroids or rituximab.\n* ES cohort only: Diagnosis of secondary ES.\n* ES cohort only: Life-threatening hemolysis.\n* ES cohort only: patients with autoimmune hemolytic anemia other than wAIHA","ALL","18 Years",{"count":20,"type":21},164,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to investigate the tolerability of ianalumab (9 mg\u002Fkg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.",[27,28],"Primary Immune Thrombocytopenia (ITP)","Primary Evans Syndrome (ES)",[30,31,32,33,34,35],"Immune thrombocytopenia (ITP)","Evans syndrome (ES)","Ianalumab","VAY736","B-cell depletion","B-cell Activating Factor Receptor (BAFF-R)","RECRUITING","2026-07-01",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":21},"2026-06-29",{"date":44,"type":21},"2030-08-08",{"name":46,"class":47},"Novartis Pharmaceuticals","INDUSTRY",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100629605","rhtpo-dose-escalation-vs-eltrombopag-switch-in-itp-100629605","NCT07476846","rhTPO Dose Escalation vs Eltrombopag Switch in ITP","Drug Switching Strategy Study After rhTPO Second-Line Treatment Failure in ITP: A Randomized Controlled Trial Comparing High-Dose rhTPO Versus Eltrombopag","Inclusion Criteria:\n\n1. Age 12-75 years, either sex;\n2. ECOG performance status 0-1;\n3. Diagnosis of ITP confirmed by bone marrow biopsy (valid within 3 months) or other relevant examinations;\n4. Patients who failed short-term rhTPO second-line treatment (≤14 days of medication) (PLT \\\u003C 30×10⁹\u002FL);\n5. Major organ function must meet the following requirements (based on normal values at the clinical trial center):\n\n   1. Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; no abnormalities other than ITP, except: a) PLT \\\u003C 30×10⁹\u002FL at Day 1 visit or within 48 hours of Day 1 is acceptable for enrollment; b) Hemoglobin: if anemia is clearly due to ITP (excessive bleeding related to thrombocytopenia), subjects with hemoglobin below the lower limit of normal may be enrolled based on investigator judgment;\n   2. Blood biochemistry: total bilirubin (TBIL) ≤ 1.5×ULN; ALT, AST, or ALP ≤ 3×ULN; serum creatinine (Cr) ≤ 1.5×ULN with creatinine clearance ≥ 50 mL\u002Fmin;\n   3. Coagulation function: prothrombin time (PT) within ±3s of normal range; activated partial thromboplastin time (APTT) ≤ 1.5×ULN unless on medications known to alter INR and APTT; no history of coagulation abnormalities other than ITP;\n6. Previous ITP combination treatments including platelet transfusion, immunoglobulin, immunomodulators, and cyclophosphamide rescue therapy must have ended ≥2 weeks before enrollment; corticosteroids or TPO-class drug treatments must have ended ≥2 weeks before study start;\n7. Patients on immunosuppressants (including corticosteroids, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) or platelet-elevating traditional Chinese medicine maintenance therapy must have stable therapeutic doses for at least the most recent month; patients receiving CD20 monoclonal antibody must have stopped treatment ≥6 months before enrollment; splenectomy patients may enroll ≥6 months after surgery;\n8. Women of childbearing potential must have negative serum pregnancy test within 24 hours before first dose; all subjects must agree to use effective contraception during the study and for 6 months after study treatment completion;\n9. No contraindications to rhTPO and eltrombopag use;\n10. Voluntary participation in this study, signed informed consent, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Refractory ITP patients (failure of first-line and second-line thrombopoietic drugs and CD20 monoclonal antibody treatment, or splenectomy failure\u002Fpostoperative relapse);\n2. Pregnant or lactating patients;\n3. Evidence of secondary causes of ITP (e.g., untreated Helicobacter pylori infection, leukemia, lymphoma, autoimmune diseases such as SLE, Hashimoto's thyroiditis) or drug-induced (e.g., anticonvulsants, antibiotics, heparin), or bicytopenia\u002Fpancytopenia such as Evans syndrome, immune-related cytopenias, etc.;\n4. History or current presence of primary diseases other than ITP causing thrombocytopenia (e.g., primary myelodysplastic syndrome \\[MDS\\], congenital bone marrow failure diseases \\[e.g., Fanconi anemia, dyskeratosis congenita\\], aplastic anemia \\[AA\\]), and judged by investigator as unsuitable for this study;\n5. History of intracranial hemorrhage or other important organ severe bleeding (\\>CTC AE Grade 3), or history of symptomatic gastrointestinal bleeding (e.g., hematemesis, melena) within 6 months before screening (occult blood test positivity without symptoms\u002Fsigns and hemorrhoids excluded);\n6. History of any arterial or venous thrombosis within 6 months before enrollment (including stroke, TIA, MI, DVT, or PE) AND presence of at least 2 of the following risk factors: hormone replacement therapy, oral contraceptives (including estrogen), smoking, diabetes, hypercholesterolemia, drug-controlled hypertension, hereditary coagulation disorders;\n7. Severe cardiovascular disease within 6 months before enrollment (NYHA Class III-IV), known arrhythmia increasing thromboembolic risk such as atrial fibrillation, coronary stent implantation, angioplasty, or post-CABG patients;\n8. Coexisting malignancy severely affecting survival;\n9. Continuous use of medications affecting platelet function (including but not limited to aspirin, clopidogrel, and\u002For NSAIDs) or anticoagulant therapy \\>3 days from 2 weeks after study start until study end;\n10. Use of any herbal medicine or nutritional supplements within 1 week before study start, except vitamin and mineral supplements;\n11. Currently having severe or uncontrolled infection (CTC AE Grade 2 infection);\n12. Laboratory or clinical evidence of HIV infection, previous hepatitis C clinical history, previous hepatitis B infection, or active hepatitis\u002Factive tuberculosis at screening. Screening laboratory tests indicating hepatitis C or hepatitis B infection (defined as positive HBsAg; additionally, if HBsAg negative but HBcAb positive, regardless of HBsAb status, HBV DNA testing is required, and if positive, subject should be excluded);\n13. Patients considered by investigator as unsuitable for this trial due to any other medical, social, or psychological factors that may affect safety or compliance with study procedures.","12 Years","75 Years",{"count":59,"type":21},112,[61],"NA","This study is a prospective, multicenter, randomized controlled study, planning to enroll 110 ITP patients who failed to respond to conventional-dose rhTPO (300 IU\u002Fkg\u002Fd) after 14 days of treatment (PLT \\\u003C 30×10⁹\u002FL). After a 2-week washout period, they will be randomized to the rhTPO double-dose group (Group A) and EPAG-pfos group (Group B), with blood routine monitored weekly and doses adjusted according to platelet levels, comparing the response rates of the two groups at 6 weeks after switching treatment.",[27],[65,66,67],"ITP","recombinant human thrombopoietin","eltrombopag","NOT_YET_RECRUITING","2026-06-30",{"date":37,"type":40},{"date":72,"type":21},"2026-06",{"date":74,"type":21},"2028-03",{"name":76,"class":77},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100642347","phase-2-a-study-of-ianalumab-in-addition-to-eltrombopag-in-pediatric-patients-with-primary-itp-who-failed-corticosteroids-100642347","NCT07660172","A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.","A Phase 2, Open-label, Single-arm Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary Immune Thrombocytopenia Who Had an Insufficient Response to or Relapsed After First-line Corticosteroid Treatment (VAYHIT-P).","VAYHIT-P","Inclusion Criteria:\n\n* Signed informed consent and\u002For assent must be obtained from the participant and\u002For their parent(s)\u002Flegal guardian(s) before any study-related activity or assessment is performed. Informed consent must be obtained from participants once they reach the local legal age of adulthood during the study.\n* Male or female patients aged 5 to \\\u003C18 years on the day of signing informed assent\u002Fconsent (as appropriate for age).\n* A confirmed diagnosis of primary ITP, with insufficient response to, or relapse after a firstline corticosteroid therapy with or without IVIG.\n* Patients with platelet count \\\u003C30 G\u002FL for whom eltrombopag is clinically indicated (per physician's discretion) and with no contraindications to receive eltrombopag.\n* Patients who are up-to-date on childhood vaccinations as per the local recommended vaccination schedule.\n\nExclusion Criteria:\n\n* Patients with ITP who received previous second-line ITP treatments (other than corticosteroid therapy with or without IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (maximum one week) before or during screening are eligible.\n* Patients with key renal or hepatic laboratory abnormalities.\n* Patients with other hematologic diagnosis associated with cytopenias, including Evans Syndrome.\n* Patients with current or history of life-threatening bleeding due to thrombocytopenia.\n* Patients who are Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) positive.\n* Patients with known active or uncontrolled infections requiring systemic treatment during the screening period or history of recurrent clinically significant infection.\n* Patients with hepatic impairment (Child-Pugh score \\>5, or equivalent).\n* Patients with concurrent bleeding disorders or coagulation disorders and\u002For receiving antiplatelet or anticoagulant medication.\n* Female patients who are nursing or pregnant.\n\nOther protocol-defined inclusion\u002Fexclusion may apply.","5 Years","17 Years",{"count":89,"type":21},36,[24],"The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to \\\u003C18 years of age) with primary ITP who have had an insufficient response to or relapsed after first-line treatment with corticosteroids.",[27],[94,65,33,95,96,67,97],"Primary Immune Thrombocytopenia","ianalumab","first-line corticosteroid treatment","Pediatric patients","2026-06-22",{"date":100,"type":40},"2026-06-25",{"date":102,"type":21},"2027-02-08",{"date":104,"type":21},"2033-04-22",{"name":46,"class":47},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100557929","phase-3-a-study-to-assess-the-efficacy-and-safety-of-efgartigimod-iv-in-adult-participants-with-primary-immune-thrombocytopenia-100557929","NCT06544499","A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia","A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia","advance NEXT","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF).\n* Has documented baseline mean platelet count of \\\u003C30 x 10\\^9\u002FL before randomization\n* Has a documented duration of primary immune thrombocytopenia (ITP) of more than 12 months on the date of informed consent form (ICF) signature.\n* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, intravenous immunoglobulin (IVIg), anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.\n* Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).\n* Has documented prior response defined as 1 platelet count of ≥50 × 109\u002FL to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature: prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin\n\nExclusion Criteria:\n\n* Other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of ITP, confound the results of the study or put the participant at undue risk.\n* Secondary ITP\n* Nonimmune thrombocytopenia\n* Autoimmune hemolytic anemia\n* ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.",{"count":115,"type":21},69,[117],"PHASE3","The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fadvancenext",[27],"2026-04-29",{"date":122,"type":40},"2026-05-01",{"date":124,"type":40},"2024-10-18",{"date":126,"type":21},"2028-06",{"name":128,"class":47},"argenx",94,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100402301","phase-4-eltrombopag-combining-rituximab-versus-eltrombopag-in-the-management-of-primary-immune-thrombocytopenia-itp-in-adults-100402301","NCT04518475","Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults","A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients","Inclusion Criteria:\n\n1. Signed written informed consent\n2. Age from 18 to 60 years old\n3. Diagnosed with ITP and have a platelet count of \\\u003C30 ×10\\^9\u002FL on Day 1 (or within 48 hours prior to dosing on Day 1).\n4. Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy.\n5. Subjects treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a dose after enrollment.\n6. No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \\>450msec or QTc \\>480 for patients with a Bundle Branch Block.\n7. No pre-existing infection within the last 1 months(including but not limited to pulmonary infection)\n8. Laboratory tests for coagulation function showed that prothrombin time (PT\u002FINR) and activated partial thromboplastin time (APTT) no exceed normal by more than 20%. No history of clotting disorder, other than ITP.\n9. White blood cell count, neutrophil absolute value, hemoglobin, within the reference range, with the following exceptions:\n\n   * Hemoglobin: females and males 10.0 g\u002Fdl are eligible for inclusion,\n   * Absolute neutrophil count (ANC) ≥1500\u002FµL (1.5×109\u002FL) is required for inclusion\n10. The following blood chemistry test result no exceed normal by more than 20%:alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serum albumin must not be below the lower limit of normal (LLN) by more than 10%.\n11. Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study.\n12. Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned.\n\nExclusion Criteria:\n\n1. Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.\n2. Pregnant or lactating women;\n3. Subjects is currently receiving treatment with another study medication.\n4. Any laboratory or clinical evidence for HIV infection.\n5. Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis B (HB). In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.\n6. History of platelet aggregation that prevents reliable measurement of platelet counts.\n7. Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.","60 Years",{"count":139,"type":21},224,[141],"PHASE4","This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and \u002For splenectomy.",[27],[145,146,67,147],"immune thrombocytopenia","autoantibody","rituximab","2026-04-24",{"date":120,"type":40},{"date":151,"type":40},"2020-08-10",{"date":153,"type":21},"2030-08-10",{"name":76,"class":77},1,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":155},"100635949","phase-3-high-dose-dexamethasone-combined-with-orelabrutinib-versus-high-dose-dexamethasone-combined-with-placebo-in-adult-patients-with-newly-diagnosed-primary-immune-thrombocytopenia-100635949","NCT07559331","High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia","A Randomized Controlled Study of High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Subjects must thoroughly understand the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to enrollment. They must understand the study procedures and voluntarily sign the informed consent form.\n2. Male or female subjects aged 18-80 years (inclusive).\n3. Body weight ≥35 kg at screening.\n4. Adult patients with newly diagnosed, untreated primary ITP, with platelet count (PLT) \\\u003C30×10⁹\u002FL and no active bleeding in vital organs.\n5. Subjects who responded to prior treatment with oral dexamethasone 40 mg\u002Fday for 4 days, defined as meeting all three of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT ≥30×10⁹\u002FL; ② ≥2-fold increase from baseline; and ③ no active bleeding. Between Week 2 and Week 12, any abnormal PLT result meeting any of the following criteria must be confirmed by repeat testing at Qilu Hospital within 24-48 hours: ① PLT \\\u003C30×10⁹\u002FL; ② \\\u003C2-fold increase from baseline; or ③ active bleeding.\n6. Women of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days following the last dose of study medication.\n\nExclusion Criteria:\n\n1. Subjects with severe ITP at screening (e.g., life-threatening thrombocytopenia, major bleeding events, or requiring urgent treatment including intravenous immunoglobulin, high-dose glucocorticoids, or plasma exchange), whom the investigator anticipates will require rescue treatment within 2 weeks after enrollment.\n2. Subjects with autoimmune systemic diseases other than ITP, unless the investigator determines that such conditions will not affect the evaluation of study outcomes.\n3. Subjects who failed to respond to prior treatment with oral dexamethasone 40 mg\u002Fday for 4 days, defined as meeting any of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT \\\u003C30×10⁹\u002FL; ② \\\u003C2-fold increase from baseline; or ③ active bleeding.\n4. History of intracranial hemorrhage within 6 months prior to screening.\n5. Subjects with a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.\n6. Subjects with a known hypersensitivity to any component of the study drugs described in this protocol.\n7. Known human immunodeficiency virus (HIV) infection, or positive serologic test results.\n8. Subjects with positive tuberculosis screening test (based on interferon-gamma release assay, including T-SPOT®, etc.), or active, latent, or incompletely appropriately treated tuberculosis at screening.\n9. Activated partial thromboplastin time (aPTT) ≥1.5× upper limit of normal (ULN) or international normalized ratio (INR) ≥1.5 at screening.\n10. Organ dysfunction, with the following laboratory findings at screening: Absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL; hemoglobin \\\u003C90 g\u002FL; lymphocyte count \\\u003C0.8×10⁹\u002FL. Total bilirubin \\>1.2×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>ULN. Amylase or lipase \\>2×ULN. Estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73 m² calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Immunoglobulin IgG \\\u003C6 g\u002FL.\n11. Pregnant or lactating women.\n12. Subjects unable to undergo blood collection, or with contraindications to phlebotomy.\n13. Any other condition that the investigator considers unsuitable for participation in this trial.","80 Years",{"count":165,"type":21},86,[117],"This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia.",[27],"2026-04-23",{"date":171,"type":40},"2026-04-30",{"date":173,"type":40},"2026-04-08",{"date":175,"type":21},"2028-12-31",{"name":177,"class":77},"Shandong University",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100610871","phase-3-an-open-label-study-of-intravenous-immunoglobulin-5-for-the-treatment-of-primary-immune-thrombocytopenia-100610871","NCT07233213","An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia","An Open-label, Single-arm, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Human Immunoglobulin for Intravenous Injection (5%) in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. At the time of signing the informed consent form, male or female patients aged ≥ 18 years and ≤ 65 years;\n2. Patients with clinically confirmed chronic ITP (i.e., the course of disease \\> 12 months from diagnosis to signing the informed consent form);\n3. Patients who did not use glucocorticoids for at least 2 weeks before the first dose or used a maintenance dose of glucocorticoids for at least 2 weeks before the first dose, and did not plan to increase the dosage of glucocorticoids or add other platelet-elevating drugs within 4 weeks after the first dose;\n4. Platelet count \\\u003C 30 × 109\u002FL;\n5. Patients who understand the procedures and methods of this study, are willing to sign the informed consent form and complete the study in strict accordance with the clinical study protocol.\n\nExclusion Criteria:\n\n1. Patients who are known or suspected to be allergic to human immunoglobulin or other plasma proteins and\u002For blood products, as well as excipients of the investigational drug, including those with a history of steroid hormone allergy;\n2. BMI ≥ 30 kg\u002Fm2;\n3. Secondary thrombocytopenia;\n4. Patients with the following clinical manifestations or disease history at screening:\n\n   * Hemoglobin \\\u003C90 g\u002FL or combined with immune hemolytic anemia;\n\n     * Chronic or recurrent neutropenia (defined as absolute neutrophil count \\\u003C 1.5 × 109\u002FL);\n\n       * Patients with abnormal liver function: defined as ALT and\u002For AST \\> 3 times of the upper limit of normal; and\u002For total bilirubin ≥ 1.5 times of the upper limit of normal;\n\n         * Patients with related diseases of renal impairment, or serum creatinine ≥ 1.5 times the upper limit of normal value or creatinine clearance \\\u003C 60 mL\u002Fmin; ⑤. Patients with dysglycemia, including: Confirmed diagnosis of type 1\u002F2 diabetes mellitus with HbA1c ≥7.0%, Fasting glucose ≥7.0 mmol\u002FL (126 mg\u002FdL), or Random glucose ≥11.1 mmol\u002FL (200 mg\u002FdL);\n\n           ⑥. Blood diseases with coagulation factor defects;\n\n           ⑦. Selective IgA deficiency patients with anti-IgA antibodies;\n\n           ⑧. Patients with uncontrollable hypertension (SBP\\>160 mmHg or DBP\\>100 mmHg) or hypotension (SBP\\\u003C90 mmHg or DBP\\\u003C60 mmHg);\n\n           ⑨. Patients with hyperviscosity, severe cardiovascular and cerebrovascular diseases (such as TIA, stroke, thrombotic disease, congestive heart failure of NYHA classification III\u002FIV, arrhythmia requiring drug therapy (unstable angina pectoris) or myocardial infarction, etc.) and other serious systemic diseases before signing the informed consent form, who are not suitable for enrollment as judged by the investigator;\n\n           ⑩. Suffering from mental illness, obvious mental disorder or epilepsy; incapacitated or cognitively impaired;\n5. Patients who failed to respond to previous treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin;\n6. Patients who had received treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin within 4 weeks prior to the first dose, or any other treatment with blood, blood products or blood derivatives within 4 weeks before signing the informed consent form;\n7. Patients who have received recombinant human thrombopoietin or eltrombopag and other receptor agonists within 2 weeks prior to the first dose (except for those who are ineffective after stable treatment \\> 2 weeks), or other drugs with clear indications of increasing platelet count;\n8. Patients who have received immunosuppressive or other immunomodulatory drugs within 3 weeks prior to the first dose (except for the following cases: glucocorticoids with stable dose and no dose change for \\> 2 weeks, and patients who failed to respond to stable treatment with azathioprine, cyclophosphamide or danazol for \\> 12 weeks);\n9. Patients who received rituximab within 8 weeks prior to the first dose;\n10. Patients who have been vaccinated with live attenuated vaccines within 8 weeks prior to the first dose or are planned to be vaccinated during the trial treatment, such as poliomyelitis vaccine, measles vaccine, rubella vaccine, mumps vaccine and varicella virus vaccine; patients who are planned to be vaccinated with measles vaccine within 1 year after the administration of the investigational drug;\n11. Patients scheduled for surgery during the trial and requiring transfusion of blood or blood products;\n12. Those who planned to continue taking non-steroidal anti-inflammatory drugs, warfarin and other drugs that affect platelet aggregation or coagulation function due to medical history during the trial;\n13. Patients who tested positive for any of HBs antigen (or nucleic acid test), HCV antibody (or nucleic acid test), Treponema pallidum antibody and HIV antibody (or nucleic acid test) at screening;\n14. Acute bacterial or acute viral infections that still require antibiotic treatment after enrollment;\n15. Pregnant and lactating women who have aborted for less than 30 days before signing the informed consent form (currently breastfeeding or currently not artificially breastfeeding but less than one year after delivery); female patients or spouses of male patients who plan to get pregnant or donate eggs or male patients who donate sperm during the trial and within 90 days after the last dose, and effective contraception cannot be guaranteed;\n16. Patients with a history of drug abuse or drug addiction;\n17. Patients who have participated (already included) in clinical trials of other drugs or medical devices within 3 months before signing the informed consent form;\n18. The survival time is expected to be less than 3 months, or the patients with other concomitant diseases are severely ill and may be dying during the treatment period and follow-up period. In the investigator's opinion, the efficacy cannot be evaluated or it is unlikely to complete the expected course of treatment and follow-up;\n19. Patients with poor compliance or who are not suitable to participate in this trial for other reasons as judged by the investigator.","65 Years",{"count":89,"type":21},[117],"It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG). This clinical study is conducted to evaluate the efficacy and safety of 5% IVIG in patients with primary Immune Thrombocytopenia (ITP).\n\nThe study includes 4 periods and 9 visits (designated as V):\n\n* Screening period (V1: 14 days before the first administration, preliminary examination);\n* Baseline Period (V2: within 24 h before the first dose, Day 0);\n* Treatment Period (V3: Day 1 to Day 5, administration of the drug in a hospital setting);\n* Follow-up Period (V4-V9: visits to Study Site on Day 6, Day 7, Day 14 + 2, Day 21 + 3, Day 28 + 4, and Day 90 (+ 14) after the first dose).\n\nIn this study, the investigational product 5% IVIG will be administered at a dose of 0.4 g\u002Fkg\u002Fday (direct intravenous drip) for 5 consecutive days. The total duration of your participation in the study will be approximately 104 days. The investigational product will only be provided during the study period. It will not be supplied after the study ends.\n\nThe study will be conducted at clinical centers in Turkey. It is planned to obtain data from 36 patients included in the study (no more than 48 screened patients).",[27],[191,192],"autoimmune hemorrhagic disease","hemorrhage","2026-04-07",{"date":173,"type":40},{"date":196,"type":40},"2025-11-24",{"date":198,"type":21},"2026-12",{"name":200,"class":47},"Grand Shuyang Life Sciences (Chengdu) Co., Ltd.",9,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100583727","phase-1-study-of-pn20-in-adult-patients-with-primary-immune-thrombocytopenia-itp-100583727","NCT06880081","Study of PN20 in Adult Patients With Primary Immune Thrombocytopenia (ITP)","A Phase 1b, Open-label, Single-arm, Dose-escalation Study of PN20 in Patients With Primary Immune Thrombocytopenia (ITP)","Key Inclusion Criteria:\n\n1. Aged between 18 and 65 years (inclusive), male or female;\n2. Diagnosed with primary immune thrombocytopenia (ITP) and have a disease course of more than 6 months;\n3. Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP (such as glucocorticoids, immunoglobulin) and have failed to respond or relapsed after treatment;\n4. During screening period, the mean of two platelet counts must be \\\u003C 30 × 10\\^9\u002FL, with none \\>35 × 10\\^9\u002FL;\n5. Fully understand and are able to comply with the requirements of the protocol, voluntarily participate and sign the informed consent form.\n\nKey Exclusion Criteria:\n\n1. History of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.\n2. Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.\n3. Diagnosed with arterial thrombotic disease (such as cerebral thrombosis, transient ischemic attack, myocardial infarction, peripheral arterial disease, etc.); Patients with a history or complications of venous thrombosis (such as deep vein thrombosis, pulmonary embolism); or patients who are using anticoagulants or antiplatelet drugs at the beginning of screening.\n4. Subjects who have used romiplostim or its analogs in the past and have not responded.\n5. Subjects who have used eltrombopag, haitubopag, avatubopag, recombinant human thrombopoietin (rhTPO), or other drugs with c-MPl stimulating effects within the 4 weeks prior to signing the ICF.\n6. Received any anti-malignancy agents (e.g., cyclophosphamide, mercaptopurine, vincristine, vinblastine, interferon-alfa) within 8 weeks prior to signing the ICF.\n7. Less than 4 weeks since end of any clinical trials about therapeutic drug or device prior to signing the ICF.\n8. Laboratory abnormalities with clinical significance at screening visit.\n9. In the opinions of investigators, the patients are not suitable for participation in this trial.",{"count":210,"type":21},12,[212],"PHASE1","The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with primary immune thrombocytopenia (ITP). The main questions it aims to answer are:\n\n* Is PN20 safe in these patients?\n* Could these patients potentially benefit from PN20 treatment?\n\nParticipants will\n\n* Receive one subcutaneous injection of PN20 according to weight;\n* Visit the clinic for assessment.",[27],[27,216,217],"thrombopoietin receptor agonist","PN20","2026-02-26",{"date":220,"type":40},"2026-03-02",{"date":222,"type":40},"2025-03-07",{"date":224,"type":21},"2026-04-28",{"name":226,"class":47},"Chongqing Peg-Bio Biopharm Co., Ltd.",5,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":163,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":155},"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","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.",{"count":237,"type":21},28,[24],"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.",[27],[242,243,244],"primary immune thrombocytopenia","orelabrutinib","romiplostim N01","2026-02-03",{"date":247,"type":40},"2026-02-10",{"date":249,"type":21},"2026-04-01",{"date":251,"type":21},"2028-10-01",{"name":253,"class":77},"Peking Union Medical College Hospital",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":261,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":273,"locationsCount":275},"100587508","phase-1-a-phase-ibii-clinical-trial-of-multiple-doses-of-stsa-1301-subcutaneous-injection-in-healthy-subjects-and-patients-with-immune-thrombocytopenia-itp-100587508","NCT06929299","A Phase Ib\u002FII Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n\\- (stage I):\n\n1. 18 years ≤ age ≤ 50 years, male or female subjects;\n2. Body mass index is 18 kg\u002Fm\\^2≤ BMI≤ 26kg\u002Fm\\^2;\n3. Subjects (including the subject's partner) are willing to use effective contraception during the study period and have no plans to have children or to donate sperm or eggs from the time of signing the informed consent form until 3 months after the last dose;\n4. Pre-randomization medical history had no effect on enrollment in the trial, and physical examination, laboratory test items, and all tests related to the trial were normal or the investigator determined that the abnormalities were not clinically significant;\n5. Subjects are aware of the risks of the trial and voluntarily participate in this clinical trial and sign an informed consent form.\n\n(stage 2):\n\n1. Aged 18 to 75 years, inclusive, and of either gender.\n2. Clinically diagnosed with persistent or chronic primary immune thrombocytopenia (ITP) with no known other causes of thrombocytopenia.\n3. The ITP diagnosis of the subject is supported by a prior response to ITP treatment with a platelet count reaching ≥50×10\\^9\u002FL.\n4. One platelet test during the screening period and one during the baseline period (with an interval of at least 7 days), with an average platelet count \\\u003C30×10\\^9\u002FL and no single platelet count \\>35×10\\^9\u002FL. No severe bleeding within 4 weeks prior to the screening visit.\n5. Subjects who have previously failed at least one first-line standard ITP treatment (corticosteroids and\u002For intravenous immunoglobulin) (defined as inability to maintain efficacy or relapse), or are intolerant to first-line standard treatment.\n6. The study allows the concurrent use of the following ITP treatment medications at a stable dose: oral corticosteroids, danazol, dapsone, oral immunosuppressants (azathioprine, methotrexate, cyclosporine A, mycophenolate mofetil), or TPO-RA (limited to oral small molecule non-peptide). A stable dose means that the treatment dose and frequency have been stable for at least 4 weeks prior to randomization and are not expected to change during the study.\n7. The subject (including the subject's partner) is willing to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of study drug, and has no plans for pregnancy or sperm\u002Fegg donation during this period.\n8. The subject fully understands and is able to comply with the requirements of the study protocol and voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n\\- (stage I)\n\n1. Subject has a history of serious medical conditions (including, but not limited to, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, pulmonary, immunologic, psychiatric, or cardiovascular disorders) or any disease or sequela known to be likely to interfere with the absorption, distribution, metabolism, or excretion of the test drug;\n2. Subjects with an active infection or with a serious infection (resulting in hospitalization or requiring parenteral antibiotic therapy) within 6 weeks prior to the first dose; subjects with a combination of clinically significant active or chronic uncontrolled bacterial, viral, or fungal infections at screening;\n3. Subjects have a history of immunodeficiency;\n4. Subjects had a history of malignant tumors;\n5. Subjects who are hypersensitive to the product or any of its ingredients; history of eczema, asthma or other allergic diseases;\n6. Current active tuberculosis, including pulmonary and extrapulmonary tuberculosis; tuberculosis-related imaging changes in the lungs (e.g., cavities, infiltrative lesions) detected by chest X-ray; and a history of close contact with an active case of tuberculosis in the past 1 year.\n7. Subject's total IgG at Screening\u002FBaseline is less than the lower limit of normal. Subject has an absolute neutrophil count \\\u003C1.5X10\\^9\u002FL and\u002For an absolute lymphocyte count \\\u003C1.0× 10\\^9\u002FL;\n8. Positive Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb), Hepatitis C Virus Antibody (Anti-HCV), Syphilis Specific Antibody, and Positive HIV Antibody (Anti-HIV);\n9. Those with clinically significant abnormalities on electrocardiogram (ECG) examination as judged by the clinical investigator (one repeat is permitted to determine eligibility);\n10. The subject has any condition that interferes with blood collection (including difficulties in blood sample collection, etc.);\n11. Consumption of more than 5 cups of coffee, tea, or cola (150mL each) per day in the 3 months prior to screening;\n12. Smoked more than 5 cigarettes or equivalent amount of tobacco per day in the 3 months prior to screening;\n13. Regular drinkers in the 6 months prior to screening, i.e., more than 2 units of alcohol per day (1 unit = 360mL of beer or 45mL of spirits at 40% alcohol or 150mL of wine) in the 6-month period; and abnormal breath test results for alcohol during the Screening Period or Baseline Period;\n14. Subjects with a history of substance abuse within 1 year prior to screening; positive urine substance abuse screen at baseline;\n15. Blood loss or blood donation \\>400mL within 3 months prior to screening or history of blood transfusion or any blood product use within 3 months prior to enrollment;\n16. Participation as a subject in any drug or vaccine or medical device clinical trial within 3 months prior to screening;\n17. Vaccinated or scheduled to be vaccinated within 4 weeks prior to screening up to 3 months after the end of dosing;\n18. Taken medications that may affect immune function within 6 months prior to screening or received any monoclonal antibody or biologic therapy within 3 months prior to screening and prescription\u002Fover-the-counter medications, herbs, or other supplements within 14 days prior to screening;\n19. Women who are pregnant or breastfeeding;\n20. Subjects who, in the opinion of the investigator, have any factors that make participation in this trial inappropriate.\n\n(stage 2)\n\n1. Thrombocytopenia associated with other conditions such as lymphoma, chronic lymphocytic leukemia, viral infections, hepatitis, induced or alloimmune thrombocytopenia, thrombocytopenia associated with abnormal bone marrow development, or hematopoietic stem cell transplantation.\n2. Abnormalities in any of the following laboratory tests at screening or at baseline: a. Total IgG level \\\u003C 6 g\u002FL. b. International normalized ratio (INR) \\> 1.5 or activated partial thromboplastin time (APTT) \\> 1.5 x ULN. c. Alanine aminotransferase (ALT) ≥ 3× ULN or aspartate aminotransferase (AST) ≥ 3× ULN.\n3. Clinical evidence of significantly unstable or poorly controlled acute or chronic disease other than ITP (e.g., cardiovascular, pulmonary, hematologic, gastrointestinal, endocrine, hepatic, renal, neurologic, infectious, poorly controlled diabetes mellitus) present at the time of screening, recent major surgical procedures, or any other medical condition that, in the opinion of the investigator, may affect the results of the study or the safety of the subject.\n4. Prior comorbidities or treatments: a. Use of anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) or any medication with antiplatelet effects within 4 weeks prior to randomization. b. Any blood transfusion within 4 weeks prior to randomization. c. Received Ig (IV, SC, or intramyocardial routes) or plasma exchange (PLEX) or anti-D immunoglobulin therapy within 4 weeks prior to randomization. d. Use of recombinant human thrombopoietin or Romiplostim within 6 months prior to randomization. e. Use of rituximab or other anti-CD20 agents other than rituximab within 6 months prior to randomization. f. Splenectomy within 3 months prior to randomization. g. Live\u002Fattenuated vaccine within 8 weeks prior to randomization. h. Vaccination within 8 weeks prior to randomization. i. Vaccination within 8 weeks prior to randomization. j. Vaccination within 8 weeks prior to screening. k. Receipt of any inactivated, subunit, polysaccharide, or conjugate vaccine at any time prior to screening is not considered an exclusion criterion. h. Use of other complementary therapies that have been evaluated by the investigator at as potentially interfering with the subject's efficacy assessment and safety, including but not limited to: herbal medicines, herbal remedies, or manipulations (e.g., acupuncture) within the greater of 4 weeks or 5 half-lives prior to randomization.\n5. Prior history of malignancy, except for cured carcinoma in situ.\n6. Any thrombotic or embolic event within 12 months prior to randomization, or history of any major thrombotic or embolic event within 5 years (e.g., myocardial infarction, stroke, deep vein thrombosis, or pulmonary embolism).\n7. History of coagulation disorders or hereditary thrombocytopenia or family history of thrombocytopenia.\n8. Presence of active, clinically significant organ or internal mucosal bleeding requiring urgent treatment or therapeutic manipulation (e.g., intracranial hemorrhage, pulmonary hemorrhage, hemorrhage persistently requiring transfusion of concentrated red blood cells) within 6 months prior to screening.\n9. In the judgment of the investigator, it is predicted that there may be a higher risk of clinically significant organ or internal mucosal hemorrhage requiring urgent treatment or therapeutic manipulation during the study period (e.g., intracranial hemorrhage, pulmonary hemorrhage, hemorrhage that consistently requires transfusion of concentrated red blood cells).\n10. Presence of clinically significant active or chronic bacterial, viral, or fungal infections at screening or at baseline; or acute or chronic infectious diseases requiring systemic therapy with antibiotics, antivirals, antiparasitics, or antifungals within 4 weeks prior to randomization.\n11. Hepatitis B surface antigen (HBsAg) positive at screening, or hepatitis B core antibody (HBcAb) positive+ Hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive, or hepatitis C virus (HCV) antibody positive+ Hepatitis C virus ribonucleic acid (HCV-RNA) positive, or human immunodeficiency virus (HIV) antibody or syphilis antibody positive.\n12. Currently has active tuberculosis, including pulmonary and extrapulmonary tuberculosis; chest X-ray reveals tuberculosis-related imaging changes in the lungs (e.g., cavities, infiltrative lesions).\n13. Hypersensitivity reactions to the study drug are known to exist.\n14. Participated in a clinical study of another FcRn inhibitor in the previous 6 months and received at least 1 administration.\n15. Have used the investigational drug within 3 months or 5 half-lives (whichever is longer) prior to randomization.\n16. Being pregnant or breastfeeding at screening or at baseline or having plans to become pregnant during the study.\n17. Presence of an autoimmune disease other than ITP at screening or at baseline.\n18. Other conditions that, in the judgment of the investigator, make participation in this study inappropriate.",true,{"count":263,"type":21},56,[212,24],"A randomized, double-blind, placebo-controlled design was designed to evaluate the safety and tolerability, pharmacokinetic\u002Fpharmacodynamic profile, and immunogenicity of multiple administration of STSA-1301 subcutaneous injection in healthy subjects and patients with ITP, and to further explore the initial efficacy of STSA-1301 subcutaneous injection in patients with ITP",[27],"2026-01-15",{"date":269,"type":40},"2026-01-16",{"date":271,"type":40},"2025-05-12",{"date":72,"type":21},{"name":274,"class":47},"Jiangsu BioJeTay Biotechnology Co., Ltd.",7,{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":155},"100607542","phase-4-sequential-rhtpo-and-eltrombopag-following-glucocorticoids-for-severe-adult-itp-100607542","NCT07189910","Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITP","Efficacy and Safety of Glucocorticoids Combined With Recombinant Human Thrombopoietin (rhTPO) Sequential Eltrombopag Olamine for Severe Primary Immune Thrombocytopenia (ITP) in Adults","Inclusion Criteria:\n\n* Age between 12 and 75 years, regardless of gender;\n* ECOG performance status of 0-1;\n* Diagnosis of primary ITP confirmed by bone marrow biopsy (valid within 3 months) and other relevant assessments; baseline platelet count (PLT) \\\u003C20×10⁹\u002FL within 48 hours prior to administration of study medication;\n* Adequate function of major organs as defined below (based on the clinical laboratory reference ranges of the study center):\n* Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; no abnormalities unrelated to ITP, except a) PLT \\\u003C20×10⁹\u002FL at Day 1 or within 48 hours of Day 1 is allowed; b) Hemoglobin: If anemia is clearly due to ITP-related bleeding, hemoglobin lower than the lower limit of normal (LLN) may be permitted at investigator's discretion.\n* Biochemistry: Total bilirubin (TBIL) ≤1.5×ULN; ALT, AST, ALP ≤3×ULN; serum creatinine ≤1.5×ULN and creatinine clearance ≥50 mL\u002Fmin.\n* Coagulation: Prothrombin time (PT) within ±3 seconds of normal range; activated partial thromboplastin time (APTT) ≤1.5×ULN unless on medications known to alter INR\u002FAPTT; no known history of coagulopathy other than ITP.\n* Prior ITP rescue treatments (e.g., platelet transfusion, IVIG, immunomodulators, cyclophosphamide) must have ended or failed at least 2 weeks prior to enrollment (except corticosteroids); TPO-RAs or corticosteroids must be discontinued ≥14 days before study start.\n* Patients on maintenance immunosuppressive therapy (e.g., corticosteroids, azathioprine, danazol, cyclosporine A, mycophenolate mofetil, or traditional Chinese platelet-raising medicine) must be on stable doses for at least 1 month prior to enrollment. Patients previously treated with anti-CD20 antibodies must have discontinued at least 6 months prior; splenectomy patients may enroll ≥6 months post-surgery.\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 24 hours prior to first dosing; all subjects agree to use effective contraception during the study and for 6 months after its completion.\n* No known contraindications to corticosteroids, rhTPO, or eltrombopag and willing to undergo rhTPO followed by eltrombopag treatment.\n* Willingness to participate and ability to provide written informed consent. For participants aged ≥12 years, both the subject and their legal guardian must sign the informed consent form.\n\nExclusion Criteria:\n\n* Refractory ITP (failure to respond to first- and second-line TPO-RAs, anti-CD20 therapy, or splenectomy);\n* Pregnant or lactating women;\n* Evidence of secondary ITP (e.g., untreated Helicobacter pylori, leukemia, lymphoma, autoimmune diseases such as SLE, Hashimoto's thyroiditis), drug-induced thrombocytopenia (e.g., due to anticonvulsants, antibiotics, heparin), or multi-lineage autoimmune cytopenias (e.g., Evans syndrome);\n* History or presence of any primary disease other than ITP that may cause thrombocytopenia (e.g., myelodysplastic syndrome, congenital bone marrow failure syndromes such as Fanconi anemia or dyskeratosis congenita, aplastic anemia), as judged by the investigator;\n* History of intracranial hemorrhage or severe bleeding (\\>CTCAE Grade 3) of vital organs; symptomatic gastrointestinal bleeding (e.g., hematemesis, melena) within 6 months prior to screening (asymptomatic occult blood and hemorrhoids excluded);\n* History of any arterial or venous thrombosis (e.g., stroke, TIA, MI, DVT, PE) within 6 months prior to enrollment and at least two of the following risk factors: hormone replacement therapy, oral contraceptives (including estrogens), smoking, diabetes, hypercholesterolemia, pharmacologically controlled hypertension, hereditary thrombophilia;\n* Severe cardiovascular disease within 6 months prior to enrollment (e.g., NYHA Class III-IV), arrhythmias increasing thrombotic risk (e.g., atrial fibrillation), or history of coronary stenting, angioplasty, or bypass surgery;\n* Concurrent serious or life-threatening malignancy;\n* Use of drugs that significantly affect platelet function (e.g., aspirin, clopidogrel, NSAIDs) or anticoagulants for \\>3 days within 2 weeks before and during the study;\n* Use of any herbal medicine or nutritional supplement within 1 week prior to study start, except for vitamins and minerals;\n* Ongoing or uncontrolled serious infections (≥CTCAE Grade 2);\n* Laboratory or clinical evidence of HIV infection, active hepatitis C, active hepatitis B, or previous history of these infections. Patients with positive HBsAg are excluded. Those with HBsAg-negative but HBcAb-positive must undergo HBV DNA testing; if positive, they are excluded;\n* Any condition deemed by the investigator to make the subject unsuitable for participation, including but not limited to medical, social, or psychological factors affecting safety or study compliance.",{"count":284,"type":21},150,[141],"To address the clinical need for improving early response rates, maintaining sustained responses, reducing relapse rates, and minimizing adverse events in the treatment of immune thrombocytopenia (ITP), the investigators developed a comprehensive in-hospital and post-discharge management strategy. In this study, hospitalized participants will receive a 14-day regimen of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO), followed by a 10-week course of oral eltrombopag olamine dry suspension after discharge. The investigators aim to evaluate the efficacy and safety of this sequential treatment strategy in adult ITP patients.",[27],[289,290,291],"immune thrombocytopenia (ITP)","recombinant human thrombopoietin (rhTPO)","Eltrombopag","2025-09-23",{"date":294,"type":40},"2025-09-24",{"date":296,"type":21},"2025-12-01",{"date":298,"type":21},"2027-12-31",{"name":300,"class":77},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":155},"100584409","early-phase-1-safety-study-of-cc312-in-autoimmune-disease-patients-100584409","NCT06888960","Safety Study of CC312 in Autoimmune Disease Patients","An Exploratory Clinical Study on the Safety of CC312 in Treating Patients With Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects who fully understand the objectives, nature, methods of the study, and possible adverse reactions, voluntarily participate as subjects, and sign the informed consent form (ICF).\n* Age ≥18 years (inclusive, based on the time of signing ICF), male or female.\n* For SLE:\n\n  1. Subjects who are diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)\u002F1997 American College of Rheumatology (ACR) diagnostic classification criteria;\n  2. SLEDAI-2000 score of ≥ 8 points and at least one BILAG grade A or two BILAG grade B under standard treatment conditions;\n  3. Meet one of the following conditions: antinuclear antibody (ANA) determined to be positive during the screening period, or anti-dsDNA antibodies higher than normal levels at screening, or anti-Sm antibodies higher than normal levels at screening;\n  4. Before the first dose of the investigational drug, subjects must have received at least one of the following standard treatments for 12 weeks, and the dose must have been stable for at least 30 days (dose reduction is allowed and dose increase is not allowed ). Standard treatment regimen refers to the stable use of any of the following (alone or in combination): a. Antimalarial (hydroxychloroquine) monotherapy; b. Antimalarials in combination with oral corticosteroids (OCS, e.g., prednisone or other hormones at equivalent doses) and\u002For immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, ciclosporin, azathioprine, Tripterygium wilfordii); c. OCS and\u002For immunosuppressant combination therapy. If the subject is receiving OCS (e.g., prednisone or other hormones at equivalent doses), the following criteria must be met: at screening and during the screening period, the maximum dose of OCS is 30 mg\u002Fday of prednisone (or other hormones at equivalent doses); other drugs and traditional Chinese medicines that affect immunity may be continued at the discretion of the investigator.\n* For IIM:\n\n  1. According to the 2017 EULAR\u002FACR Classification Criteria, diagnosed as possible or definite IIM-possible IIM: with a score of 5.5 points without biopsy; definite IIM: with a score of 6.7 points with biopsy;\n  2. Meeting one of the following criteria: During or before the screening period, confirmed to have at least one positive myositis-specific autoantibody (MSA), myositis-associated autoantibody (MAA), or ANA;\n  3. Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: the use of glucocorticoids (prednisone \\>1 mg\u002Fkg\u002Fd or equivalent dose) and\u002For at least one immunomodulatory drug: such as antimalarial drugs, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, tacrolimus, ciclosporin, and\u002For biological drug products: such as rituximab and belimumab.\n* For IIM:\n\n  1. Subjects who are diagnosed with SSc according to the 2013 EULAR\u002FACR diagnostic classification criteria;\n  2. Meets one of the following criteria: positive ANA confirmed during or before the screening period, or at least one positive SSc-related antibody profile (such as Scl70, Th\u002FTo, RP11\u002F12, U3RNP autoantibodies);\n  3. Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: using glucocorticoids (prednisone \\> 0.5 mg\u002Fkg\u002Fd or equivalent dose) and cyclophosphamide, and any of the following immunomodulatory drugs: such as antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, ciclosporin, and\u002For biological agents: such as rituximab and belimumab, with a cumulative treatment duration \\> 6 months.\n* For RA:\n\n  1. Diagnosed with RA according to the 2010 EULAR\u002FACR diagnostic classification criteria;\n  2. Disease Activity Score DAS28-ESR \\>3.2 (i.e., moderate activity or higher) during the screening period;\n  3. Failure after treatment with at least one conventional disease-modifying antirheumatic drug (DMARD) and\u002For at least one targeted synthetic DMARD (tsDMARD)\u002Fbiologic DMARD (bDMARD) (defined as no remission after at least 3 months of treatment);\n  4. At screening, if the subject is taking prednisone or an equivalent dose of a glucocorticoid, the dose must be ≤10 mg\u002Fday and stable for at least 4 weeks before the first dose;\n  5. The subject must have discontinued traditional Chinese medicine for the treatment of RA for ≥4 weeks before the first dose;\n  6. Other DMARDs, except for methotrexate (MTX) (subjects who have been on routine MTX treatment for 12 weeks before enrollment, with a stable MTX dose for 4 weeks before enrollment), must meet the washout period requirements: discontinuation of conventional synthetic DMARDs (csDMARDs) (including but not limited to sulfasalazine, leflunomide, penicillamine, azathioprine, ciclosporin A, cyclophosphamide, hydroxychloroquine, etc.) and herbal agents (including Tripterygium wilfordii, total glucosides of paeony, sinomenine, etc.) for 4 weeks before the first dose; discontinuation of intra-articular, intramuscular, or intravenous corticosteroids for 4 weeks before the first dose; discontinuation of anakinra and etanercept for 4 weeks before the first dose; discontinuation of adalimumab and infliximab for 8 weeks before the first dose; discontinuation of golimumab, certolizumab pegol, and tocilizumab for 10 weeks before the first dose; discontinuation of abatacept for 12 weeks before the first dose; in addition, stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted to be continued.\n* For ITP:\n\n  1. Diagnosed with ITP according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 Edition);\n  2. Ineffective response or relapse after at least one prior treatment regimen (including but not limited to TPO mimetics\u002Fagonists, corticosteroids, immunoglobulins, azathioprine, cyclophosphamide, and\u002For rituximab);\n  3. At least 2 platelet count measurements (with an interval of more than 24 hours) from the screening period to before the first dose, with an average platelet count \\\u003C30×109\u002FLand no single platelet count\\>35×109\u002FL;\n  4. If receiving standard background therapy for ITP, the dose and frequency of this therapy should be stable for at least 4 weeks (dose change ≤10%) before the first dose.\n* For AIHA:\n\n  1. Diagnosed with AIHA according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Autoimmune Haemolytic Anaemia (2022 Edition);\n  2. Poor response after at least first-line treatment (corticosteroids);\n  3. Presence of anaemia-related symptoms during the screening period;\n  4. The dose of supportive care must be stable for at least 4 weeks before the first dose.\n* Laboratory test results:\n\nComplete blood count:\n\n1. SLE, SSc, and IIM: Absolute neutrophil count ≥1.0 x109\u002FL, haemoglobin ≥60 g\u002FL, platelets ≥50 x109\u002FL;\n2. RA: Neutrophil count ≥1.5 x109\u002FL, haemoglobin ≥90 g\u002FL, platelets ≥100 x109\u002FL;\n3. ITP: Absolute neutrophil count ≥1.0 x109\u002FL, haemoglobin ≥70 g\u002FL, platelets ≥10 x109\u002FL;\n4. AIHA: Absolute neutrophil count ≥1.0 x109\u002FL, platelets ≥50 x109\u002FL (≥10 x109\u002FL for patients with Evans syndrome and transfusion is permitted).\n\nLiver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 times the upper limit of normal (ULN), and total serum bilirubin ≤1.5×ULN (≤3.0×ULN for Gilbert's syndrome) or if bilirubin abnormality is caused by the study disease, participation is allowed upon investigator's judgment.\n\nRenal function: For RA, ITP, and AIHA: Serum creatinine ≤1.5 times ULN, or calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula).\n\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Female subjects of childbearing potential must agree to use effective contraception from the screening period until 6 months after the last dose. Additionally, they must agree to refrain from collecting or donating eggs during this period; any male partners of reproductive potential must also agree to use effective contraceptive measures during this period.\n* Male subjects with reproductive potential must agree to use effective contraception from the screening period to 6 months after the last dose, and have no plans for reproduction or sperm donation. During this period, their female partners of childbearing potential must also agree to use effective contraception.\n\nExclusion Criteria:\n\n* Subjects who have severe lupus nephritis (defined as urinary protein \\>6 g\u002F24 h or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL), or required treatment of active nephritis with protocol-prohibited drugs, or required hemodialysis or received prednisone ≥100 mg\u002Fd or equivalent glucocorticoid therapy for ≥14 days within 8 weeks before screening.\n* Subjects who have central nervous system diseases caused by SLE or not caused by SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, posterior reversible encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.).\n* Other types of IIM: inclusion body myositis, diabetic amyotrophy, juvenile myositis; severe muscle injury or myositis causing permanent weakness or cardiac involvement due to non-IIM causes (e.g., stroke).\n* Pulmonary arterial hypertension associated with SSc requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active antral vascular ectasia; previous renal crisis caused by SSc.\n* Significant organ transplantation (e.g., heart, lung, kidney, liver) or history of hematopoietic stem cell\u002Fbone marrow transplantation.\n* Concomitant presence of two or more immune diseases requiring systemic treatment, if the investigator deems the subject unsuitable for enrollment.\n* IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL).\n* Have participated in any other clinical trials (including cell or gene therapy) within 4 weeks before screening or within 5 half-lives of the investigational product (whichever is longer).\n* Have received CAR-T therapy within 6 months before screening.\n* Have received B-cell depleting drug rituximab or equivalent treatments (targeting CD19, CD20, BAFF, etc.) within 1 month before screening, unless it can be demonstrated that B cells have returned to pre-treatment levels or within the normal range.\n* Have received anti-SLE treatments (e.g., Saphnelo) other than standard therapy within 3 months before screening or within 5 half-lives of the investigational product (whichever is longer).\n* Have received a live\u002Fattenuated vaccine within 4 weeks before screening or plans to receive a live\u002Fattenuated vaccine during the study.\n* Active infection.\n* History of Grade 3-4 (CTCAE v5.0) allergic reaction to another monoclonal antibody treatment, or known allergy to any component or excipient of the CC312 drug product (including recombinant proteins, polysorbate 80, etc.); patients with a ≤Grade 3 allergy lasting \\\u003C24h may participate in this study after discussion with the investigator.\n* Acknowledgement of or evidence of illicit drug use, drug abuse, or alcoholism.\n* Subjects who have received major surgery within 4 weeks before screening or minor surgery within 2 weeks; wounds must be completely healed (surgical procedures such as catheter placement are not exclusion criteria).\n* History of any of the following cardiovascular diseases within 6 months before screening: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease.\n* Any other serious underlying diseases (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation dysfunction, heart diseases), mental illnesses, psychological, familial, or endemic diseases that, in the investigator's judgment, may interfere with the planned staging, treatment, and follow-up; affect subjects; compliance; or expose the subjects to a higher risk of complications.\n* Evidence of concurrent malignant tumors within less than 5 years before screening, excluding adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma of stage ≤T1. Subjects with prostate cancer undergoing active surveillance are eligible for this study.\n* Pregnant or breastfeeding women.\n* Subjects with positive results for viral serological tests during the screening period: positive for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody (TP-Ab).\n* Subjects with active or latent tuberculosis (positive T-SPOT) identified during the screening period.\n* History of splenectomy treatment within 6 months prior to screening.\n* ITP subjects: 1) Secondary immune thrombocytopenia secondary to SLE, chronic lymphocytic leukemia (CLL), immunodeficiency common variable (CVID), or antiphospholipid syndrome (APS); 2) Drug-induced thrombocytopenia; 3) Any bleeding event requiring treatment within 4 weeks prior to screening; 4) Within 2 weeks prior to screening, the subject has continuously used drug therapy that affects platelet function (including but not limited to aspirin, aspirin-containing compounds, clopidogrel, salicylates, and\u002For NSAIDs) for \\>3 days; 5) History of any arterial or venous thrombosis (stroke, transient ischaemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or clinical symptoms and medical history suggestive of thrombophilia; or any of the following: known arrhythmia that increases the risk of thrombotic events (e.g., atrial fibrillation), or corrected QT interval (QTc) \\>450 msec; or a history of other coagulation abnormalities.\n* ITP and AIHA subjects: Abnormal prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) that are considered clinically significant by the investigator.\n* Other subjects whom the investigator judges to be unsuitable for this study.",{"count":309,"type":21},18,[311],"EARLY_PHASE1","This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy.\n\nCC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the \"biopharmaceutical version\" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy.\n\nThe study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A \"3+3\" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.",[314,315,316,317,27,318],"Systemic Lupus Erythematosus (SLE)","Idiopathic Inflammatory Myopathy (IIM)","Systemic Sclerosis (SSc)","Rheumatoid Arthritis (RA)","Autoimmune Hemolytic Anemia","2025-09-11",{"date":321,"type":40},"2025-09-17",{"date":323,"type":40},"2024-11-08",{"date":325,"type":21},"2026-11-08",{"name":327,"class":47},"CytoCares Inc",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":155},"100594446","phase-2-a-phase-ii-trial-aiming-to-investigate-the-safety-and-clinical-activity-of-belantamab-mafodotin-in-adult-patients-with-primary-immune-thrombocytopenia-previously-treated-with-a-thrombopoietin-receptor-agonist-andor-rituximab-after-corticosteroid-first-line-therapy-100594446","NCT07019545","A PHASE II TRIAL AIMING TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN IN ADULT PATIENTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA PREVIOUSLY TREATED WITH A THROMBOPOIETIN RECEPTOR AGONIST AND\u002FOR RITUXIMAB AFTER CORTICOSTEROID FIRST-LINE THERAPY","BONSAI","Inclusion Criteria:\n\n1. Participant must be 18 years or older.\n2. Primary ITP with platelet cell count of less than 30x10\\^9\u002FL.\n3. Prior first-line therapy with corticosteroids.\n4. Prior second-line therapy with TPO-RA and\u002For rituximab and failure to achieve or retain response.\n5. Adequate organ system function as defined by the below laboratory assessments. Hematologic\n\n   1. Absolute neutrophil count ≥1.5 X 10\\^9\u002FL; granulocyte colony stimulating factor use within the past 14 days is NOT permitted.\n   2. Hemoglobin ≥8.0 g\u002FdL; transfusions within the past 14 days are NOT permitted. Erythropoietin use is allowed. Hepatic\n\n   \u003C!-- -->\n\n   1. Total bilirubin ≤1.5xULN (isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%).\n   2. Alanine aminotransferase ≤ 2.5xULN. Renal\n\n   a. Estimate glomerular filtration rate ≥30 mL\u002Fmin\u002F1.73 m\\^2; calculated using the Modified Diet in Renal Disease formula.\n6. Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a woman of childbearing potential (WOCBP) defined as follows:\n\n     1. ≥45 years of age and has not had menses for \\>1 year.\n     2. Participants who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation.\n     3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure. OR\n   * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency during the intervention period and for 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of trial intervention.\n   * WOCBP must have a negative highly sensitive serum pregnancy test at screening within 72 hours of dosing on C1D1 and agree to use a highly effective method of contraception during the trial and for 4 months after the last dose of belantamab mafodotin. Additional requirements for pregnancy testing during and after trial intervention are provided in Section 10. Trial Procedures and Visit Schedule. The investigator is responsible for a review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.\n7. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials: Male participants are eligible to participate if they agree to the following during the intervention period and until 6 months after the last dose of belantamab mafodotin, whichever is longer, to allow for clearance of any altered sperm.\n\n   • Refrain from donating sperm\n\n   PLUS either:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR\n   * Must agree to use contraception\u002Fbarrier as detailed below:\n\n   Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n8. Eastern Cooperative Oncology Group Performance (ECOG) Status ≤ 2.\n9. Participants must be able to understand the trial procedures and agree to participate in the trial by providing written informed consent.\n\nExclusion Criteria:\n\n1. Secondary ITP including:\n\n   i. Drug induced ITP. ii. ITP associated with any autoimmune disorders (e.g., systemic lupus erythematosus and rheumatoid arthritis). iii. ITP associated with chronic infection (e.g., human immunodeficiency virus, hepatitis C virus and helicobacter pylori). iv. ITP associated with malignancy (e.g., chronic lymphocytic leukemia or large granular T-lymphocyte lymphocytic leukemia). v. ITP associated with chronic infection.\n2. Chronic liver disease. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.\n3. To be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]) at screening or within 3 months prior to first dose of trial treatment.\n\n   NOTE 1: Participants with resolved infection (i.e., participants who are positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] or antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR). Those who are PCR positive will be excluded.\n\n   NOTE 2: presence of ant-iHBs indicating previous vaccination will not constitute an exclusion criterion.\n4. To be seropositive for hepatitis C at screening or within 3 months prior to first dose of trial treatment.\n\n   NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.\n5. Known HIV infection unless the participant can meet all of the following criteria:\n\n   1. Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \\\u003C400 copies\u002FmL\n   2. CD4+ T-cell (CD4+) counts ≥350 cells\u002FuL\n   3. No history of AIDS-defining opportunistic infections within the last 12 months NOTE: consideration must be given to ART and prophylactic antimicrobials that may have a drug:drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant.\n6. Active infection requiring treatment.\n7. Presence of active renal condition (infection, requirement for dialysis, or any other significant condition that could affect participant's safety).\n8. Any serious and\u002For unstable pre-existing medical or psychiatric disorder, or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance to the trial procedures.\n9. Participant must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.\n10. Current corneal epithelial disease except for mild punctate keratopathy. NOTE: Participants with mild punctate keratopathy are allowed. Mild (Grade 1) punctuate keratopathy is characterized by the appearance of only a few, if any, microcyst-like epithelial changes, as identified in the slit-lamp examination, with a low density (non-confluent), and predominantly (≥80%) located in the periphery of the cornea.\n11. Known intolerance or immediate or delayed hypersensitivity reaction or idiosyncratic reaction to: drugs chemically related to belantamab mafodotin, or any of the components of the trial treatment; or infused protein products, sucrose, histidine, and polysorbate 80.\n12. Use of an investigational drug within 14 days or 5 half-lives (whichever is shorter) preceding the first dose of trial drug.\n13. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of trial drug. Please note, monoclonal antibodies for serious conditions unrelated to MM, such as COVID, may be permitted but need to be discussed with the Sponsor.\n14. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.\n15. Evidence of active mucosal or internal bleeding.\n16. Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.\n17. Major surgery within 4 weeks before the first dose of trial drug NOTE 1: participant must be clinically stable following a major surgery to be entered in the trial.\n\nNOTE 2: major surgery shall be defined based on the Investigator's judgment according to the extent and complexity of the procedure, its pathophysiological consequences and consecutive clinical outcomes. 18. Evidence of cardiovascular risk including any of the following: i. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities, second degree (Mobitz Type II), or third degree atrioventricular block. ii. Screening 12-lead ECG showing a baseline QT interval \\>470 msec iii. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening. iv. Class III or IV heart failure as defined by the New York Heart Association functional classification system (Appendix 3 - New York Heart association (NYHA) Classification v. Uncontrolled hypertension.",{"count":336,"type":21},14,[24],"This is a Phase II open label, prospective, multicenter trial designed to assess the safety and clinical activity of belantamab mafodotin in adult patients with primary immune thrombocytopenia (ITP) previously treated with a thrombopoietin receptor agonist (TPO-RA) and\u002For rituximab after first-line treatment with corticosteroids. Overall, 14 participants will be enrolled in the trial. Participants' follow-up will continue for up to 12 months after the last participant is enrolled. The accrual period will be approximately 12 months.\n\nTrial treatment will be given in 28-day cycles for a total period of one year per patient or until treatment failure, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Participants without confirmed Response (R) or better after two infusions with belantamab mafodotin will be discontinued from trial treatment and will not be replaced.",[27],"2025-06-05",{"date":342,"type":40},"2025-06-13",{"date":344,"type":21},"2025-06-20",{"date":346,"type":21},"2027-06-20",{"name":348,"class":77},"Hellenic Society of Hematology",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":155},"100592338","phase-2-romiplostim-n01-combined-with-glucocorticoids-as-the-first-line-treatment-for-newly-diagnosed-adult-primary-immune-thrombocytopenia-a-multicenter-interventional-trial-100592338","NCT06992128","Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial","Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP): A Multicenter, Interventional Trial","Inclusion Criteria:\n\n1. Sign the written informed consent form before enrollment;\n2. Age ranging from 18 to 75 years old;\n3. Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;\n4. have not received any prior treatments for ITP.\n5. Have not received romiplostim treatment;\n6. ECOG PS score: 0 - 2;\n7. Platelet value \\\u003C 30×10\\^9\u002FL;\n8. The expected survival period at the screening is ≥ 12 weeks;\n9. For subjects of reproductive age, agree to take reliable contraceptive measures throughout the study period (including male or female condoms, contraceptive foams, contraceptive gels, contraceptive membranes, contraceptive ointments, contraceptive suppositories, abstinence, and intrauterine device placement, etc.); Female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or menopause for more than 1 year, and male subjects who have undergone bilateral vasectomy or ligation are excluded;\n10. Voluntarily join this study, sign the informed consent form, and have good compliance.\n\nExclusion Criteria:\n\n1. Suffering from other secondary thrombocytopenia except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferative diseases, multiple myeloma, myelodysplastic syndrome, common variable immunodeficiency, and hereditary thrombocytopenia, etc.;\n2. Having undergone splenectomy before the first administration;\n3. Having received ITP drug treatment (including emergency treatment) before the first administration;\n4. Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4 weeks before the first administration;\n5. Having received hematopoietic growth factor preparations (such as granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11, etc.) within 4 weeks before the first administration;\n6. Having received antibody drugs (such as rituximab, etc.) within 14 weeks before the first administration;\n7. Having received any Chinese herbal medicine or nutritional supplement (except vitamin supplements and mineral supplements) for the purpose of increasing platelets within 1 week before the first administration;\n8. Having been diagnosed with arterial thrombosis (such as cerebral thrombosis, transient ischemic attack or myocardial infarction), or having a history or complication of venous thrombosis (such as deep vein thrombosis, pulmonary embolism), or using anticoagulants or antiplatelet drugs at the beginning of screening;\n9. Having a history of severe cardiovascular diseases (such as grade III\u002FIV congestive heart failure, arrhythmia or angina pectoris that increases the risk of thromboembolic events, unstable angina pectoris, having undergone coronary artery stent implantation, angioplasty or coronary artery bypass grafting);\n10. Secondary thrombocytopenia caused by autoimmune diseases such as antiphospholipid antibody syndrome, systemic lupus erythematosus, Hashimoto's thyroiditis, Even's syndrome and Sjogren's syndrome;\n11. Positive results for either human immunodeficiency virus antibody or syphilis antibody screening; positive hepatitis C antibody and HCV-RNA exceeding the upper limit of the study center's laboratory test; positive hepatitis B surface antigen and HBV-DNA exceeding the upper limit of the study center's laboratory test;\n12. Having participated in other clinical studies within 3 months before the first administration;\n13. Being pregnant or lactating, or having a pregnancy plan;\n14. Having fertility and being judged by the researcher as not fully adopting contraceptive measures;\n15. Having a history of severe drug allergic reactions or being known to be allergic to glucocorticoids or Nplate® (romiplostim) or the components of QL0911;\n16. Unable to comply for mental reasons;\n17. Judged by the researcher as not suitable to participate in this trial;",{"count":357,"type":21},129,[24],"This prospective, multicenter, randomized study aim to evaluate the efficacy and safety of romiplostim N01 combined with glucocorticoids as the first-line treatment for newly diagnosed adult primary immune thrombocytopenia (ITP).",[27],[65,362,363,364],"Romiplostim","Continuous Remission","First-line Treatment","2025-05-19",{"date":367,"type":40},"2025-05-28",{"date":369,"type":21},"2025-05-22",{"date":371,"type":21},"2028-08-31",{"name":76,"class":77},{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":380,"maxAge":4,"enrollmentInfo":381,"targetDuration":383,"studyType":384,"phases":4,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":89},"100586743","resti-registry-spanish-registry-of-primary-immune-thrombocytopenia-and-other-immune-thrombocytopenia-100586743","NCT06919341","RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia","RESTI","Inclusion Criteria:\n\n* Children as young as 2 months of age and adults in follow-up since 2015 (irrespective of date of diagnosis) with the diagnostic presumption of PIT or other thrombocytopenia of probable immune origin defined as a platelet count \\\u003C 100 x 109\u002FL.\n* Patients who have given written informed consent. In the case of deceased patients, the data will be included in the registry and the investigator will record the impossibility of collecting patient's informed consent form due to death. Only patients deceased after December 31 2015, will be included\n\nExclusion Criteria:\n\n* Patients who, at the investigator's discretion, do not meet the conditions for inclusion in the study","2 Months",{"count":382,"type":21},1000,"1 Year","OBSERVATIONAL","Primary immune thrombocytopenia (PIT), previously referred to as idiopathic thrombocytopenic purpura, is an acquired disease characterized by accelerated platelet destruction and deficient platelet production by megakaryocytes.\n\nAlthough the existence of PIT has been known for decades, there is no consensus on its triggering mechanisms. On the other hand, this disease presents a very heterogeneous patient profile, both in its characteristics and treatments. In this sense, the diagnosis is still made by excluding other causes of thrombocytopenia.\n\nThere is insufficient epidemiological data on the disease, a fact that is especially evident in our country. We have no data on the incidence or prevalence of this pathology in Spain.\n\nFor all these reasons, this epidemiological study has been designed to increase the available knowledge about this disease and the detailed characterization of the population of patients with ITP in Spain.\n\nThe main objective of this study is to describe the clinical, analytical and treatment characteristics of primary immune thrombocytopenia and other immune thrombocytopenia.\n\nThe study is an epidemiological, ambispective, multicenter study carried out in hospitals in Spain.\n\nInformation will be collected on the disease under study, as well as on the treatments received, using the patient's clinical history as a source document.",[387,27],"ITP - Immune Thrombocytopenia",[65,389,390,391],"PTI","Trombocitopenia inmune primaria","Primary Inmune Thrombocytopenia","2025-04-07",{"date":394,"type":40},"2025-04-09",{"date":396,"type":40},"2024-09-27",{"date":398,"type":21},"2034-09",{"name":400,"class":77},"Fundación Española de Hematología y Hemoterapía",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":155},"100465244","phase-3-efficacy-and-safety-of-subcutaneous-belimumab-or-placebo-in-addition-of-rituximab-in-persistent-or-chronic-immune-thrombocytopenia-100465244","NCT05338190","Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia","A Phase 3 Randomized and Double-blind Controlled Trial Comparing the Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition to Rituximab in Adult Patients With Persistent or Chronic Immune Thrombocytopenia (ITP)","RITUX-PLUS 2","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Primary ITP defined according to the standard definition criteria (Rodeghiero, Blood 2008)\n3. Previous response to corticosteroids and\u002For IgIV defined by a rise of platelet levels \\> 30 x 109\u002FL with at least a twofold increase from baseline levels followed by a relapse.\n4. Platelet count ≤ 30 x 109\u002FL within the previous month or \\\u003C50 x 109\u002FL if presence of haemorrhagic events or other reason left up to investigator discretion.\n5. ITP duration of more than 2 months but less than 5 years from diagnosis.\n6. Normal bone marrow smear for patients above 60 years of age\n7. Negative pregnancy test results and effective contraception for women of childbearing age Female subjects of childbearing potential must not become pregnant and so must be sexually inactive by abstinence or use contraceptive methods with a failure rate of \\\u003C 1%.\n\n   Therefore, these women must have a negative serum pregnancy test at screening, and confirmed monthly while in study (with serum or Urine test), out to at least 12 months (taking account of the longest half-life which is that of 29.7 days and according to smPC) post last dose and agree to 1 of the following:\n   * Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent (Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) OR\n   * Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent, during the study, and 16 weeks after the last dose of study agent\n\n     * Oral contraceptive, either combined or progestogen alone\n     * Injectable progestogen\n     * Implants of levonorgestrel or etonogestrel\n     * Estrogenic vaginal ring\n     * Percutaneous contraceptive patches\n     * Intrauterine device (IUD) or intrauterine system (IUS) with \\\u003C1% failure rate as stated in the product label\n     * Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, \"documented\" refers to the outcome of the investigator's\u002Fdesignee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records\n     * Double barrier method: condom and occlusive cap (diaphragm or cervical\u002Fvault caps) plus spermicidal agent (foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception.\n8. Complete Vaccinal scheme against SARS-CoV2 according to the recommendations of the health authorities\n9. Gammaglobulin level ≥ 7 g\u002FL\n10. Informed consent\n11. Affiliated to, or beneficiary of, a social security regime or similar\n\nExclusion Criteria:\n\n1. Splenectomy\n2. Previous treatment with rituximab or any B-cell targeted therapy\n3. Common variable immunodeficiency\n4. Previous treatment with cyclophosphamide or ciclosporin\n5. Inclusion in another clinical trial less than 3 months before inclusion\n6. Previous anaphylactic shock to previous biologic therapy\n7. Chronic or ongoing severe infection requiring treatment or hospitalization in the 60 days preceding inclusion.\n8. Use of parenteral antibiotics within 60 days, current use of suppressive therapy for chronic infection such as tuberculosis, pneumocystis, cytomegalovirus, HSZ, herpes zoster, and atypical mycobacteria\n9. Evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and\u002For any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.\n10. Psychiatric Illness impairing judgement.\n11. Neutrophils count \\\u003C 1,000\u002Fmm3 at inclusion\n12. Positive HIV test and\u002For hepatitis virus C infection and\u002For positive hepatitis B virus surface antigen or core antibody (HbsAg or HBcAb)\n13. Impaired renal function as indicated by a serum creatinine level \\> 2 mg\u002Fdl\n14. Liver function: AST (SGOT) and ALT (SGPT) ≥5xULN Total bilirubin ≥3 x ULN\n15. New York Heart Classification III or IV heart disease\n16. Previous history of malignancy in the last 5 years other than cutaneous carcinoma\n17. Previous history of Progressive multifocal leukoencephalopathy\n18. Previous history of major organ transplant or hematopoietic stem cell\u002Fmarrow transplant or renal transplant.\n19. Alcohol or drug abuse or dependence, either current or within 1year\n20. Pregnant or breast-feeding woman\n21. Live, attenuated vaccinations must be administered at least 30 days before inclusion in study\n22. History of significant medical illness or clinically significant laboratory abnormality (or planned surgical procedure) which in the opinion of the investigator would interfere with the study procedures and \u002F or assessments or compromise subject safety\n23. Body mass index \\> 40\n24. PCR-confirmed SARS-CoV-2 infection\n25. Vulnerable persons, under the protection of justice,\n26. Persons deprived of their liberty by judicial or administrative decision,\n27. Persons admitted to a health or social establishment for purposes other than research,\n28. Persons under legal protection (guardianship, curatorship),\n29. Persons unable to express their consent",{"count":410,"type":21},132,[117],"Primary immune thrombocytopenia (ITP) is an autoimmune disease mainly mediated by autoreactive B cells and the presence of pathogenic anti-platelet auto-antibodies that enhance platelet destruction and impair platelet production. There are approximately 4,000 newly diagnosed ITP cases each year in France. For patients with a platelet count of less than 30x109\u002FL and\u002For bleeding symptoms, corticosteroids alone or in combination with intravenous immunoglobulin (IVIg) is the standard first-line treatment. However, approximately two-thirds of adult patients responding to this first-line treatment relapse within days or weeks after corticosteroids withdrawal and overall, the course of the disease is chronic in about 70% of the cases. The anti-CD20 monoclonal antibody rituximab is commonly used off-label as a second-line therapy in many European countries including France for adults with persistent (i.e., disease duration of more than 3 months) or chronic (disease duration of more than 12 months) ITP. Rituximab leads to an overall response rate of only 40 % at 1 year but 29.5% of lasting (5 years and more) response The investigators have shown that the absence of response to rituximab in ITP could be explained by the settlement and expansion of long-lived autoreactive plasma cells in the spleen made possible by the high amount of BAFF. Belimumab is a fully humanized anti-BAFF\u002FBlys monoclonal Ab licensed for SLE. Based on the preliminary results of a phase 2 open prospective pilot study performed in our center combining rituximab with i.v belimumab seems highly promising We hypothesized that combining subcutaneous belimumab weekly over a 24 weeks period (Arm A) with rituximab is superior to rituximab and subcutaneous placebo weekly over 24 weeks period (Arm B) to achieve an overall response at W52.\n\nThe study design will be a prospective randomized, double-blind, multicenter (international), superiority phase III clinical study",[27],"2023-09-08",{"date":416,"type":40},"2023-09-11",{"date":418,"type":40},"2022-11-14",{"date":420,"type":21},"2027-11-14",{"name":422,"class":77},"Assistance Publique - Hôpitaux de Paris"]