[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-thrombocytopenia-itp\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-thrombocytopenia-itp":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,42,69,100,125,148,175,199,222,243,272,297,318,339,359,385,406,424,444,464,485,506,526],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100644969","phase-1-bioequivalence-study-of-ski-o-703-in-healthy-adults-under-fed-conditions-100644969",false,"NCT07675226","Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions","An Open-label, Randomized, Fed, Single-dose, Oral Administration, 2-treatment, 2-period, Crossover Design, Phase 1 Clinical Trial to Evaluate the Bioequivalence of SKI-O-703 in Healthy Adult Participants","Inclusion Criteria:\n\n1. Korean or Caucasian adults aged 19 years and older at screening. Caucasian: An individual whose parents and grandparents are of European, North American, or Middle Eastern origin; who was born in Europe, North America, or West Asia; and who has resided outside these regions for less than 10 years\n2. Body mass index (weight \\[kg\\] \u002F height2 \\[m\\]2) between 18 and 30 kg\u002Fm2, and body weight not less than 50 kg.\n3. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.\n4. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, blood coagulation test, urinalysis or urine drug test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents.\n5. Must sign voluntarily an informed consent form indicating they understand the purpose of, procedures required for, and comply to the prohibitions and restrictions specified in the study and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Any significant surgical\u002Fmedical procedure or trauma within 4 weeks before the planned first dose of the study drug or history of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair)\n2. Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2 \\[SARS-CoV-2\\], cough or fever, or a history of recurrent or chronic infections).\n3. Unable to swallow multiple capsules by mouth.\n4. Received an experimental drug within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled. Prior experience of participating in another clinical trial within 6 months before the planned first dose of the study drug.\n5. Individuals who have dietary habits that may influence the absorption, distribution, metabolism, or excretion of the investigational product or who consume foods known to affect drug metabolism.\n6. Before the start of the study (first day of administration) those who have donated whole blood or blood components within 8 weeks or within 2 weeks, respectively, or received a blood transfusion within 1 month, or cannot refrain from donating blood from the time of written consent until the end of the trial.\n7. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.\n8. Individual unable to abstain from alcohol-, caffeine-, or xanthine-containing products within 72 hours before the first dose of study drug and during the study or who tested positive for drug abuse, alcohol at screening or check-in (Day -1).\n\n10\\) Smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarrets, or inhalers) within 30 days before the first dose of study drug or who tested positive for cotinine(indicating active current smoking) at screening or check-in (Day -1) 11) Individuals with hypersensitive to investigational product or components of investigational product 12) A women who are pregnant or suspected of being pregnant or breastfeeding. 13) Participants who do not consent to use medically acceptable methods of contraception\\* to eliminate the possibility of pregnancy from the date of the first dose until 1 month after the last dose of the study drug.\n\n\\*Combined use of an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or a combination of at least two barrier methods with spermicide.\n\n14\\) Individuals with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.",true,"ALL","19 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions. Approximately 48 Korean and Caucasian participants will receive a single oral dose of the test drug and a single oral dose of the reference drug in a randomized sequence, separated by a washout period, with pharmacokinetic sampling and safety assessments performed throughout the study.",[27,28,29],"Bioequivalence Study in Healthy Subjects","Immune Thrombocytopenia (ITP)","Rheumatoid Arthritis (RA)","NOT_YET_RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":21},"2026-07-10",{"date":38,"type":21},"2026-12-31",{"name":40,"class":41},"Oscotec Inc.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100571496","phase-1-a-study-of-pirtobrutinib-in-participants-with-immune-thrombocytopenia-100571496","NCT06721013","A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia","A Phase 1\u002F2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia","Inclusion Criteria:\n\n* Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process\n* Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000\u002Fmicroliter (μL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy\n* Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit\n* Have a platelet count less than 30,000\u002FμL on 2 occasions at least 5 days apart in the 15 days before randomization\n* Have adequate liver, renal, and hematologic functions as defined by a table\n* Are willing to follow contraception requirements\n\nExclusion Criteria:\n\n* Have a history of any thrombotic or embolic event within 12 months before screening\n* Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization\n* Have significant cardiovascular disease\n* Have a diagnosis or history of hematologic malignancy\n* Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction (PCR) positive for HBV deoxyribonucleic acid (DNA)\n* Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA)","18 Years",{"count":51,"type":21},68,[24,53],"PHASE2","The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.\n\nThe study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it.\n\nThe study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.",[28],[57],"Primary ITP","RECRUITING","2026-06-22",{"date":61,"type":34},"2026-06-25",{"date":63,"type":34},"2025-07-30",{"date":65,"type":21},"2029-05",{"name":67,"class":41},"Eli Lilly and Company",45,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100607922","phase-2-a-study-of-efgartigimod-iv-in-participants-from-12-years-to-less-than-18-years-of-age-with-chronic-immune-thrombocytopenia-itp-100607922","NCT07194850","A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)","A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP","Inclusion Criteria:\n\n* Is aged 12 to less than 18 years when completing the informed consent process\n* Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete\n* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.\n* Has documented prior response, defined as 1 platelet count of ≥50 × 10\\^9\u002FL to at least 1 of the following ITP treatments: prednisone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin\n* Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy\n* Has documented mean platelet count of less than 30 x10\\^9\u002FL\n\nExclusion Criteria:\n\n* Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except primary ITP\n* Nonimmune thrombocytopenia\n* ITP-associated critical or severe bleeding\n* History of hereditary thrombocytopenia","12 Years","17 Years",{"count":79,"type":21},24,[53,81],"PHASE3","The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP).\n\nThe study consists of a double-blinded treatment period (DBTP) in which the participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV. At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first year open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second year (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\u002Fadvancejunior",[28,84,85,86,87,88,89],"ITP - Immune Thrombocytopenia","ITP","Immune Thrombocytopenic Purpura","Immune Thrombocytopenic Purpura ( ITP )","Idiopathic Thrombocytopenic Purpura","Idiopathic Thrombocytopenic Purpura (ITP)","2026-06-11",{"date":92,"type":34},"2026-06-12",{"date":94,"type":34},"2025-10-20",{"date":96,"type":21},"2030-10",{"name":98,"class":41},"argenx",10,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100600256","phase-2-safety-tolerability-and-efficacy-of-nvg-2089-in-participants-with-immune-thrombocytopenia-100600256","NCT07095127","Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia","An Open-Label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants With Immune Thrombocytopenia","Inclusion Criteria:\n\n* Males and female participants, age 18 to 80 years at time of screening.\n* Diagnosis of persistent (\\>3 months and ≤12 months), or chronic (\\>12 months) primary ITP. If the participant has received prior treatment for ITP, they must have a history of response to at least one previous therapy (defined as increase in platelet count to ≥ 50,000 cells\u002Fmm3 with an increase of ≥ 20,000 cells\u002Fmm3 relative to platelet count prior to treatment).\n* Asymptomatic or with minor mucocutaneous bleeding AND platelet count of ≤50,000 cells\u002Fmm3, measured on 2 occasions at least 5 days apart during the screening period.\n* (For US only) If at least one screening platelet count \\>30,000 cells\u002F mm3 and \\\u003C50,000 cells\u002Fmm3, the participant must be on at least 1 other treatment for ITP with insufficient response as evidenced by platelet count \\\u003C50,000 cells\u002F mm3.\n* If participant has received prior IVIg therapy participant must have shown a sufficient platelet response (doubling from baseline platelet count within 7 days of IVIg infusion) and must not have lost response to IVIg therapy while on treatment.\n* Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1.\n* Female participants who are sexually active with a male partner of reproductive potential must use double contraception (including a barrier contraceptive and another method) from at least 28 days prior to Screening and for 90 days after last dose of study drug; female participants must also refrain from oocyte donation for the purpose of reproduction during this period. Exceptions are made for surgically sterile participants, or post-menopausal females (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle -stimulating hormone levels \\>40 mIU\u002FmL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy). Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.\n* Male participants with female partners who are of reproductive potential must agree to the use of highly effective, barrier contraception for the duration of the study, and for 90 days after the last dose of study drug.\n* Participant is capable or has a legally authorized representative(s) (LAR\\[s\\]) capable of providing a signed informed consent which includes compliance with the requirements and restrictions listed in the ICF.\n\nExclusion Criteria:\n\n* Secondary forms of ITP (e.g., ITP secondary to infection, autoimmune diseases, lymphoproliferative diseases and medications).\n* History of splenectomy.\n* History of malignancy, unless the participant received treatment with curative intent. Participants with fully excised non-melanoma skin cancer or cervical cancer are allowed.\n* History of solid organ transplant.\n* Planned or anticipated medical or surgical procedure, including dental procedure, during the timeframe of the study conduct.\n* Clinically significant active or chronic uncontrolled bacterial, viral, or fungal infection at screening, including active viral infection at screening.\n* Any medical condition that, in the opinion of the investigator, would interfere with study evaluations or procedures, and\u002For put the participant at increased risk.\n* ECG findings of QTcF \\> 450 msec (males) or \\> 470 msec (females), poorly controlled atrial fibrillation or other clinically significant abnormalities.\n* Other significant organ dysfunction, including but not limited to, hematologic, renal, or hepatic dysfunction, as evidenced by:\n\n  1. Absolute neutrophil count ≤ 1.5 x 109 \u002FL\n  2. Hemoglobin (Hgb) \\\u003C 9 g\u002FdL\n  3. Aspartate aminotransaminase (AST) and\u002For alanine aminotransferase (ALT) ≥ 2 x the upper limit of normal (ULN),\n  4. Albumin ≤ 3 g\u002FdL\n  5. Total bilirubin ≥ 1.5 x ULN\n  6. Estimated glomerular filtration rate \\\u003C 50 mL\u002Fmin\u002F1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method\n* Any of the following at screening:\n\n  1. Active Hepatitis B Virus (HBV): Hepatitis surface antigen (HBsAg) positive\n  2. Active Hepatitis C Virus (HCV): serology positive for HCV-antibody\n  3. Human Immunodeficiency Virus (HIV) positive serology\n* Transfusion of blood, blood products (including immune globulin), or plasmapheresis within 4 weeks prior to screening.\n* Change in current ITP therapy (e.g., prednisone, methylprednisone, mycophenolate, dapsone, danazol, azathioprine, or TPO receptor agonist) or dose within 4 weeks prior to screening.\n* Receipt of dexamethasone within 4 weeks prior to screening.\n* Receipt of rituximab or an anti-CD20 agent within 6 months prior to screening.\n* Receipt of an neonatal Fc receptor (FcRn) inhibitor within 12 weeks prior to screening.\n* Receipt of IVIg within 4 weeks prior to screening.\n* Receipt of another investigational drug within 4-weeks or 5 half-lives (whichever is longer) prior to screening.\n* Concurrent treatment with other monoclonal antibody and\u002For Fc therapies.\n* Current or past history (within 12 months of screening) of alcohol, drug, or medication abuse. Positive urine drug screen at screening visit.\n* Pregnant or lactating women and those intending to become pregnant during the study or are unwilling to apply an effective birth control method (such as implants, injectables, combined oral contraceptives, intrauterine devices \\[IUDs\\], sexual abstinence, or vasectomized partner) up to 90 days after last study drug administration.\n* Poor venous access.\n* A known allergy to study drug and\u002For any of its components.","80 Years",{"count":109,"type":21},30,[53],"The purpose of the study is to evaluate the safety of NVG-2089 and to evaluate how well patients respond to this investigational treatment. NVG-2089 is a new drug that is being developed for treating patients with ITP. NVG-2089 is designed to mimic the effects of a protein called IVIg. NVG-2089 is designed to help the immune system by attaching (binding) to certain receptors in the body and activating them, which helps reduce inflammation and supports how the immune system works.",[28],[114],"Immune Thrombocytopenia, ITP","2026-05-28",{"date":117,"type":34},"2026-06-01",{"date":119,"type":34},"2025-09-30",{"date":121,"type":21},"2027-12-31",{"name":123,"class":41},"Nuvig Therapeutics, Inc.",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":107,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100639937","phase-1-cd20-monoclonal-antibody-combined-with-btk-inhibitor-for-the-treatment-of-refractory-immune-related-cytopenia-100639937","NCT07574073","CD20 Monoclonal Antibody Combined With BTK Inhibitor for the Treatment of Refractory Immune-related Cytopenia","Clinical Study on the Treatment of Refractory Immune-related Cytopenia With CD20 Monoclonal Antibody Combined With BTK Inhibitor (BTKi)","Inclusion Criteria:\n\n* Diagnosed with refractory immune-related cytopenia, including immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA);\n* Age ranging from 18 to 80 years old (inclusive of 18 and 80);\n* Expected survival time \\> 12 months;\n* Good function of major organs:\n\n  1. liver function: ALT\u002FAST \\\u003C 3 times the upper limit of normal;\n  2. kidney function: creatinine \\\u003C 100 μmol\u002FL;\n  3. lung function: indoor oxygen saturation ≥ 95%;\n  4. heart function: left ventricular ejection fraction (LVEF) ≥ 50%;\n* Peripheral superficial venous blood flow is unobstructed, capable of meeting the requirements for intravenous infusion;\n* Karnofsky score ≥ 60, ECOG ≤ 2 points.\n\nExclusion Criteria:\n\n* Women who are pregnant (with positive urine\u002Fblood pregnancy test results) or breastfeeding;\n* Those who have severe underlying heart diseases when participating in this study, including:\n\n  1. clinically significant atrial fibrillation (AF),\n  2. cardiac conduction block,\n  3. myocardial infarction (within 1 year),\n  4. congestive heart failure (CHF);\n  5. cardiac echocardiography LVEF \\\u003C 50%;\n  6. New York Heart Association (NYHA) cardiac function classification of III-IV grade;\n* Those with active bleeding or bleeding tendencies, and those who need to take anticoagulant drugs;\n* Those with organ dysfunction or uncontrollable coexisting diseases;\n* History of malignant tumors;\n* Those with active chronic hepatitis B or active hepatitis C;\n* Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome;\n* Those with uncontrollable infectious diseases;\n* As determined by the investigator, other unsuitable conditions exist.",{"count":109,"type":21},[24],"This study aims to utilize anti-CD20 monoclonal antibodies to eliminate peripheral B cells and reduce the mechanism of autoantibody production, as well as combine the mechanism of BTK inhibitors (BTKi) blocking the B cell receptor signaling pathway and inhibiting B cell activation and proliferation, for the treatment of refractory immune-related cytopenia. In this study, it includes the salvage treatment of immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), expecting to achieve a synergistic and enhancing effect. This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options. The clinical efficacy of the Zuberitamab-Orelabrutinib combination therapy (overall response rate, duration of sustained remission) will be evaluated, along with its safety profile (including infections, bleeding, cardiac toxicity), to provide a theoretical basis for their combined use in treating refractory immune-related thrombocytopenia (ITP and AIHA).",[136,137,28,138],"Anti-CD20 Monoclonal Antibody","BTK Inhibitors","Autoimmune Hemolytic Anemia (AIHA)","2026-05-19",{"date":141,"type":34},"2026-05-22",{"date":117,"type":21},{"date":144,"type":21},"2028-05-31",{"name":146,"class":147},"Qi deng","OTHER",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":172,"locationsCount":174},"100544632","phase-1-phase-1b-trial-of-ray121-in-immunological-diseases-rainbow-trial-100544632","NCT06371417","Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)","Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Age \\>= 18 and \\\u003C=75 at the time of signing informed consent form (except for BP; Age \\>=18 and \\\u003C= 85 with Karnofsky score \\>= 60% at screening)\n3. Ability to comply with the study protocol\n4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods\n5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n6. APS cohort: Established primary APS defined by the following criteria (at least one of the laboratory criteria and one of the clinical criteria must be met):\n\n   * Laboratory criteria (aPL profile)\n\n     * Persistently positive lupus anticoagulant (LA) test\n     * Persistently positive anticardiolipin (aCL) immunoglobulin G (IgG) isotype\n     * Persistently positive anti-beta-2 glycoprotein-1 (aβ2GPI) IgG isotype\n   * Clinical criteria\n\n     * Livedoid vasculopathy and presence of skin ulcer\n     * Acute\u002Fchronic aPL nephropathy\n7. BP cohort:\n\n   * 1\\) Age \\>= 18 and \\\u003C= 85 with Karnofsky score \\>= 60 %\n   * 2\\) Predominant cutaneous lesions\n   * 3\\) Diagnosis with BP with following assessments positive:\n   * a Positive direct immunofluorescence, and either\n   * b Positive indirect immunofluorescence, or\n   * c Positive serology on ELISA for BP180 autoantibody\n   * 4\\) Bullous Pemphigoid Disease Area Index (BPDAI) score \\>= 20\n   * 5\\) Weekly average of daily Peak Pruritus Numerical Rating Score (PP-NRS) \\>=4\n   * 6\\) Accept to take photograph of bullous lesions\n8. BS cohort:\n\n   * 1\\) Diagnosed with BS\n   * 2\\) Oral ulcers that occurred at least 3 times in the previous 12 month period\n   * 3\\) Have at least 2 oral ulcers over the 4 weeks prior to screening\n   * 4\\) Have at least 2 oral ulcers at Week 0\n   * 5\\) Have prior treatment with at least 1 non-biologic BS therapy\n   * 6\\) Patients who need systemic therapy as whose oral or mucocutaneous ulcers cannot be adequately controlled by topical therapy\n9. DM cohort:\n\n   * 1\\) Diagnosed with definite or probable inflammatory myopathies and categorized as DM\n   * 2\\) Patients with inadequate response to corticosteroids and\u002For immune-suppressants or intolerance to DM therapies\n   * 3\\) Manual Muscle Test-8 (MMT-8) score \\\u003C 142, with at least one abnormality in the following Core Set Measures:\n\n     * Patient Global Activity Visual Analogue Scale (PtGA-VAS) \\>= 2 cm\n     * Physician Global Activity Visual Analogue Scale (PhGA-VAS) \\>= 2 cm\n     * Global extra-muscular activity \\>= 2 cm\n     * At least one muscle enzyme \\> 1.5 times upper limit of normal (ULN)\n     * Health Assessment Questionnaire (HAQ) \\>= 0.25\n   * 4\\) Moderate to severe DM defined as CDASI activity score \\> 14\n10. IMNM cohort:\n\n    * 1\\) Clinically Diagnosed with IMNM as anti-HMGCR myopathy or anti-SRP myopathy\n    * 2\\) Creatine kinase (CK) \\> 1,000 U\u002FL\n    * 3\\) Patients who have an inadequate response to corticosteroids and\u002For immunosuppressants or intolerance to IMNM therapies\n    * 4\\) MMT-8 score \\\u003C 142\n11. ITP cohort:\n\n    * 1\\) Confirmed diagnosis of persistent\u002Fchronic ITP based on the following criteria:\n\n      * ITP defined per the current guidelines\n      * Platelet count \\\u003C= 30 × 10\\^9\u002FL on 2 consecutive occasions\n    * 2\\) Lack of an sustained adequate platelet count response to a thrombopoietin receptor agonist and at least one other ITP treatment or a second thrombopoietin receptor agonist (TPO-RA)\n    * 3\\) A history of response with an platelet counts increase more than 20 × 10\\^9\u002FL from baseline by at least one prior line of therapy\n\nExclusion Criteria:\n\n1. History of anaphylaxis or hypersensitivity to a biologic agent\n2. Active infection requiring systemic antiviral, antibiotics or antifungal\n3. Planned surgery during the study\n4. Pregnant or breastfeeding, or intending to become pregnant\n5. Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study\n6. Clinically significant ECG abnormalities\n7. Illicit drug or alcohol abuse\n8. Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjögren's syndrome in DM and IMNM)\n9. Positive for hepatitis B surface antigen\n10. Positive for hepatitis C virus antibody\n11. Positive for human immunodeficiency virus antibody\n12. Evidence of current infection with tuberculosis\n13. History of cancer within 5 years\n14. Treatment with investigational therapy within 28 days or 5 half-lives\n15. Previous and current treatment with anti-C1s antibody at any time\n16. Other complement inhibitors within 3 months\n17. Patients who receive any treatments which fall into the Prohibited Therapy Criteria\n18. Patients with an elevated alanine aminotransferase or aspartate aminotransferase \\> 1.5 × ULN in combination with an elevated total bilirubin \\> 1.5 × ULN\n19. APS cohort:\n\n    * 1\\) APS associated with other systemic autoimmune disease\n    * 2\\) Acute thrombosis (arterial or venous acute thrombosis diagnosis) within 30 days before screening\n    * 3\\) Patients with thrombotic APS without any anticoagulation treatment\n    * 4\\) Treatment with prohibited medications\n20. BP cohort:\n\n    * 1\\) Initiation of treatment with or increase in the dose of systemic or topical corticosteroid within 2 weeks\n    * 2\\) Current treatment with a drug that may cause or exacerbate BP unless the dose has been stable\n    * 3\\) Initiation of treatment with topical calcineurin inhibitor, or topical phosphodiesterase (PDE) 4 inhibitor within 7 days\n    * 4\\) Treatment with prohibited medications\n21. BS cohort:\n\n    * 1\\) BS-related active major organ involvement-ocular lesions requiring immunosuppressive therapy, pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis), gastrointestinal (e.g., ulcers along the gastrointestinal tract), and central nervous systems (e.g., meningoencephalitis) manifestations\n    * 2\\) History of venous or arterial thrombosis within 1 year\n    * 3\\) Treatment with prohibited medications\n22. DM cohort:\n\n    * 1\\) PhGA-VAS improvement \\>= 3, or clinically relevant improvement between screening and baseline\n    * 2\\) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, IMNM, juvenile DM or drug-induced myopathy\n    * 3\\) Cancer-associated myositis\n    * 4\\) Significant muscle damage\n    * 5\\) Past history of severe Interstitial lung disease flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease\n    * 6\\) Severe respiratory muscle weakness\n    * 7\\) Severe bulbar palsy\n    * 8\\) Treatment with prohibited medications\n23. IMNM cohort:\n\n    * 1\\) PhGA-VAS improvement \\>= 3, or clinically relevant improvement between screening and baseline\n    * 2\\) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, juvenile DM or druginduced myopathy\n    * 3\\) Cancer-associated myositis\n    * 4\\) Significant muscle damage\n    * 5\\) Past history of severe Interstitial lung disease (ILD) flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease\n    * 6\\) Severe respiratory muscle weakness\n    * 7\\) Severe bulbar palsy\n    * 8\\) Treatment with prohibited medications\n24. ITP cohort:\n\n    * 1\\) Secondary ITP\n    * 2\\) Clinical diagnosis or history of Myelodysplastic Syndrome or autoimmune hemolytic anemia\n    * 3\\) History of venous or arterial thrombosis within 12 months\n    * 4\\) Patients who experienced major bleeding within 4 weeks\n    * 5\\) Treatment with prohibited medications\n    * 6\\) Any laboratory test results meet either of the following criteria at screening:\n\n      * Hemoglobin \\\u003C10 g\u002FdL\n      * Thyroid-stimulating hormone \\>= 10 μIU\u002FmL","85 Years",{"count":157,"type":21},144,[24],"This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).",[161,162,163,164,165,28],"Antiphospholipid Syndrome (APS)","Bullous Pemphigoid (BP)","Behçet's Syndrome (BS)","Dermatomyositis (DM)","Immune-mediated Necrotizing Myopathy (IMNM)","2026-04-01",{"date":168,"type":34},"2026-04-02",{"date":170,"type":34},"2024-08-19",{"date":33,"type":21},{"name":173,"class":41},"Chugai Pharmaceutical",69,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100596322","phase-1-a-phase-1b2a-study-of-budoprutug-in-subjects-with-immune-thrombocytopenia-itp-100596322","NCT07043946","A Phase 1b\u002F2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)","A Phase 1b\u002F2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects With Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. Aged 18 years at the time of consent.\n2. Platelet count \\\u003C 30,000\u002FµL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of \\\u003C 30,000\u002FµL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart.\n3. Partial thromboplastin time \\\u003C 1.5 x upper limit of normal (ULN), prothrombin time \\\u003C 1.5 x ULN, total bilirubin \\\u003C 1.5 x ULN unless due to Gilbert's syndrome, or an international normalized ratio \\\u003C 1.5 at screening.\n\nExclusion Criteria:\n\n1. CD19+ B cell count \\\u003C 80 cells\u002FµL at Screening, or \\\u003C 40 cells\u002FµL if B-cell depleting therapy was received within 24 weeks to 2 years prior.\n2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity.\n3. Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study.\n4. Chronic use of anticoagulants or antiplatelet agents (e.g., aspirin, NSAIDs, thienopyridines) within 14 days before dosing through follow-up. Intermittent NSAID use is allowed.\n5. Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days.\n6. IVIg treatment within 90 days prior to Screening.\n7. Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor.\n8. Active, chronic, or latent infections including hepatitis B\u002FC or HIV.\n9. Active TB or high TB risk.",{"count":79,"type":21},[24,53],"The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.",[28,85,186,187,188],"Biologics","Monoclonal","Anti-CD19","2026-03-24",{"date":191,"type":34},"2026-03-27",{"date":193,"type":34},"2025-06-30",{"date":195,"type":21},"2028-08",{"name":197,"class":41},"Climb Bio, Inc.",20,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":124},"100624930","early-phase-1-a-clinical-study-evaluating-the-safety-and-preliminary-efficacy-of-universal-allogeneic-car-t-cell-therapy-targeting-cd19-and-bcmaqt-019cin-patients-with-refractory-primary-immune-thrombocytopenia-100624930","NCT07416032","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C)in Patients With Refractory Primary Immune Thrombocytopenia","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Refractory Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* 1\\. Participants aged ≥18 years and ≤75 years, regardless of gender.\n* 2\\. Clinically diagnosed with primary immune thrombocytopenia for no less than 6 months, with platelet counts \\\u003C 30×10\\^9\u002FL in two separate tests conducted within 15 days before the initiation of study treatment, with at least 7 days between the tests.\n* 3\\. Presence of any anti-platelet glycoprotein autoantibody (GPIb\u002FGPIX\u002FGPIIb\u002FGPIIIa\u002FGMP140) positive.\n* 4\\. Meet the criteria for refractory ITP: previously received first-line and\u002For second-line ITP treatment (first-line treatment includes corticosteroids or immunoglobulins; second-line treatment includes thrombopoietin receptor agonists (such as eltrombopag, romiplostim), rituximab, splenectomy, etc.), but ineffective (post-treatment platelet count \\\u003C30×10\\^9\u002FL, or platelet count increase less than twice the baseline value, or presence of bleeding), or relapse after initial response or difficult to maintain after discontinuation.\n* 5\\. Important organ functions are basically normal during the selection period:\n\n  1. Echocardiogram indicates ejection fraction \\>50%, ECG shows no significant abnormalities;\n  2. Creatinine clearance (CrCl) (Cockcroft-Gault formula) \\>30 mL\u002Fmin;\n  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3.0x the upper limit of normal (ULN);\n  4. Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) \\\u003C2.0x ULN (Gilbert's syndrome \\\u003C3.0x UN);\n  5. Absolute lymphocyte count (ALC) \\>0.5x10\\^9; absolute neutrophil count (ANC) \\>1x10\\^9; hemoglobin (Hb) \\>60g;\n  6. Oxygen saturation \\>92%.\n* 6\\. Female participants of childbearing potential and male participants who are partners of women of childbearing age must use medically accepted contraceptive measures or abstain for at least 12 months during and after the study treatment; female participants of childbearing age must have a negative serum HCG test within 7 days before study enrollment and must not be breastfeeding.\n* 7\\. Volunteer to participate in this clinical study, sign informed consent, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Secondary thrombocytopenia caused by myelodysplastic syndromes, splenic hyperfunction, autoimmune diseases, early aplastic anemia, atypical aplastic anemia, and thrombotic thrombocytopenic purpura, among other causes.\n* 2\\. Bone marrow examination results during the screening phase indicate bone marrow fibrosis MF\\>2 (European expert consensus scoring criteria for bone marrow fibrosis, Thiele et al., 2005) or the bone marrow examination suggests the presence of other primary conditions causing thrombocytopenia aside from ITP.\n* 3\\. History of any of the following heart diseases:\n\n  1. NYHA class II or IV congestive heart failure;\n  2. Myocardial infarction within 6 months before signing the ICF, or having undergone coronary artery bypass grafting (CABG) or coronary artery stent implantation;\n  3. Clinically significant ventricular arrhythmias or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration);\n  4. History of severe non-ischemic cardiomyopathy.\n* 4\\. Patients who have previously received gene-modified cell therapies such as TCR-T, CAR-T, CAR-NK, etc.\n* 5\\. Patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels exceeding the upper limit of detection; those who are positive for hepatitis C virus (HCV) antibodies and have positive peripheral blood HCV RNA; those who are positive for human immunodeficiency virus (HIV) antibodies; and those who test positive for syphilis.\n* 6\\. Subjects who have received the following drug treatments before the start of the study will be excluded:\n\n  1. B-cell and antibody-secreting cell (ASC) depletion therapy:\n\n     i. Subjects who have received anti-CD20 monoclonal antibody treatment (such as rituximab) within 3 months before screening will be excluded. If such treatment occurred more than 3 months but not more than 6 months before screening, and if the absolute count of peripheral blood CD19⁺ B cells is above the lower limit of normal (as determined by local or central laboratory), then enrollment may be allowed after confirmation by the investigator and the medical director of the sponsor (or designated representative).\n\n     ii. Subjects who have previously received simultaneous CD19-targeting and BCMA-targeting treatments will be excluded. Subjects who have received CD19-targeting or BCMA-targeting treatment (either one) within 6 months before screening will also be excluded. If such treatment occurred more than 6 months before screening, and if the absolute count of peripheral blood CD19⁺ B cells is above the lower limit of normal (as determined by local or central laboratory), then enrollment may be allowed after confirmation by the investigator and the medical director of the sponsor (or designated representative).\n\n     iii. Subjects who have used or adjusted the dosage of BTK and SyK inhibitors within 2 weeks before screening should be excluded. If the dosage has been stable for ≥ 2 weeks before screening, then they may be included.\n  2. Subjects who have used or adjusted TPO-RA treatment within 2 weeks before screening should be excluded. However, those who have been on a stable dose for more than 2 weeks before screening may continue treatment.\n  3. Subjects who have used IVIG or undergone plasma exchange within 4 weeks before screening should be excluded.\n  4. Subjects who have used immunosuppressants (such as cyclophosphamide, mycophenolate mofetil (MMF), azathioprine, and methotrexate) within 2 weeks before lymphocyte depletion will be excluded.\n* 7\\. Subjects who have used prednisone \\> 10 mg\u002Fday or have had dosage adjustments within 2 weeks before screening. Oral glucocorticoid treatment equivalent to ≤ 10 mg\u002Fday of prednisone is acceptable at enrollment, provided the dosage has been stable for at least 2 weeks before enrollment.\n* 8\\. Subjects with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before screening, or who currently require anticoagulation therapy.\n* 9\\. Subjects with a history of any organ system malignancy (except well-prognosed tumors such as localized basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, follicular or papillary thyroid carcinoma, etc.) within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis; or known concomitant life-threatening diseases.\n* 10\\. Subjects with any active infection or any infection requiring systemic anti-infective treatment within 30 days before screening.\n* 11\\. Any known factors, diseases, or clinically relevant medical conditions or surgical situations that the investigator believes may place the subjects at risk, interfere with treatment compliance, study implementation, or outcomes.","75 Years",{"count":208,"type":21},27,[210],"EARLY_PHASE1","This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19\u002FBCMA CAR T-cells(QT-019C) in Patients With Refractory Primary Immune Thrombocytopenia.",[28],"2026-02-10",{"date":215,"type":34},"2026-02-17",{"date":217,"type":21},"2026-02-20",{"date":219,"type":21},"2029-03-01",{"name":221,"class":147},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":124},"100615573","phase-2-a-study-of-dzd8586-in-adults-with-primary-immune-thrombocytopenia-itp-tai-shan11-100615573","NCT07294365","A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)","A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. Male and female participants ≥ 18 years of age.\n2. Diagnosed with persistent or chronic primary ITP, and an average of two platelet counts \\\u003C 30 × 10⁹\u002FL.\n3. Have failed at least one standard treatment for ITP (glucocorticoids and\u002For IVIG).\n4. Adequate bone marrow reserve and organ functions.\n5. Willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\n1. Have evidence of secondary causes of immune thrombocytopenia.\n2. Have a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.\n3. Any of previous or current treatment prohibited by protocol.\n4. Any of severe cardiac abnormalities.\n5. Active infection.\n6. Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.\n7. Known allergy to DZD8586 drug excipients or other chemical analogues.\n8. Pregnant or breastfeeding female participants.",{"count":230,"type":21},60,[53],"This is a Phase 2, open-label, randomized, multicenter study to assess the efficacy and safety of DZD8586 in patients with primary immune thrombocytopenia (ITP). The target population of this study is patients with primary ITP who had failed to respond or relapsed after receiving at least one standard therapy. Participants who meet the inclusion criteria and do not meet the exclusion criteria will be randomized to different dose groups.",[28],"2026-01-21",{"date":236,"type":34},"2026-01-22",{"date":238,"type":34},"2026-01-15",{"date":240,"type":21},"2027-12",{"name":242,"class":41},"Dizal Pharmaceuticals",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":251,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100590070","phase-3-v-immune-for-immune-thrombocytopenia-100590070","NCT06962631","V-IMMUNE® for Immune Thrombocytopenia","V-IMMUNE® for Immune Thrombocytopenia: A Prospective Multicenter Study to Evaluate the Efficacy and Safety of Human Immunoglobulin in Adult and Pediatric Participants With Immune Thrombocytopenia. TIP Study","TIP","Inclusion Criteria:\n\n* Age ≥1 year;\n* Confirmed diagnosis of immune thrombocytopenia ( newly diagnosed, persistent or chronic);\n* Platelet count ≤20,000\u002Fmm³ at the time of enrollment;\n* No other conditions that, in the investigator's opinion, could cause thrombocytopenia;\n* Agreement to use effective contraceptive practices\u002Fmethods throughout the entire study participation by female patients of childbearing potential and able to become pregnant, unless there is a documented medical contraindication.\n\nExclusion Criteria:\n\n* Non-immune thrombocytopenia\n* Active sepsis\n* Pregnancy (pregnant or breastfeeding)\n* History of hypersensitivity reaction to blood or blood products, IVIG, or any other IgG preparation\n* Intolerance to any component of V-IMMUNE®\n* Previous diagnosis of IgA deficiency, history of reactions to products containing IgA, or history of anti-IgA antibodies\n* Participation in any other study involving an investigational product\n* Known HIV, HCV, or HBV infection\n* AST (TGO) and\u002For ALT (TGP) \\>2.5× the upper limit of normal or 2.5 times baseline values\n* Serum creatinine \\>2× the upper limit of normal or 2 times baseline values\n* BUN \\>2.5× the upper limit of normal or 2.5 times baseline values\n* History of NYHA class III or IV heart failure\n* Uncontrolled hypertension with systolic BP \\>180 mmHg or diastolic BP \\>100 mmHg\n* A history of hyperviscosity states, transient ischemic attack (TIA), stroke, other thromboembolic events, or acute coronary syndrome (ACS)\n* Neoplasia under active treatment\n* Child-Pugh class B or C liver failure\n* Alcohol, opioid, or psychotropic substance abuse within the past 12 months\n* Receipt of rituximab within 6 months prior to Day 1\n* Acute or chronic conditions (e.g., but not limited to, renal disease or diseases predisposing to renal impairment, coronary artery disease, or protein-losing enteropathy) that, in the investigator's opinion, may interfere with the conduct of the study\n\nAn acquired health condition such as chronic lymphocytic leukemia, multiple myeloma, or chronic or recurrent neutropenia (absolute neutrophil count \\\u003C1,000\u002Fmm³)\n\nHistory of hemolytic anemia\n\nReceipt of any IV immunoglobin preparation within 1 month prior to Day 1\n\nUse of corticosteroids, cyclophosphamide, azathioprine, or attenuated androgens with a planned dose increase before Day 10 following IV immunoglobin infusion","1 Year",{"count":253,"type":21},31,[81],"This is a multicenter, prospective clinical trial evaluating the efficacy and safety of V-IMMUNE®, a 5% human normal immunoglobulin formulation administered intravenously, for the treatment of immune thrombocytopenia (ITP) in patients aged ≥1 year. The primary objective is to assess the proportion of patients achieving a platelet count ≥50,000\u002Fmm³ on or before Day 9 following the first infusion. The trial employs a single-group design, comparing outcomes to historical controls derived from the literature. Eligible patients must have a confirmed diagnosis of ITP with a platelet count ≤20,000\u002Fmm³ and no concurrent conditions likely to cause thrombocytopenia. Key exclusions include non-immune thrombocytopenia, active sepsis, pregnancy or lactation, hypersensitivity to blood products or IgG preparations, and various significant comorbidities (e.g., uncontrolled hypertension, severe hepatic or renal impairment, recent rituximab use). The intervention consists of V-IMMUNE® at a dose of 1 g\u002Fkg, administered once daily for two consecutive days, with infusion rates titrated from 0.01 mL\u002Fkg\u002Fmin to 0.06 mL\u002Fkg\u002Fmin. Standard pre-medication protocols (IV normal saline and diphenhydramine) are administered to mitigate infusion-related reactions and reduce the risk of thromboembolic events. Patients will be monitored at multiple time points from baseline through Day 90, with primary efficacy evaluation at Day 9. Secondary endpoints include duration of platelet response, overall treatment response rate, bleeding events, and incidence of infusion-related adverse events.",[28],[258,259,260,261,262],"phase III","clinical trial","immune thrombocytopenia","human immunoglobulin","platelets",{"date":264,"type":34},"2026-01-20",{"date":266,"type":34},"2025-07-18",{"date":268,"type":21},"2027-02-27",{"name":270,"class":147},"On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.",2,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":296},"100606433","phase-1-a-study-of-cm336-in-patients-with-relapsed-or-refractory-autoimmune-cytopenia-100606433","NCT07175493","A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia","A Phase 1\u002F2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia","Inclusion Criteria:\n\n* Voluntary provision of written informed consent and ability to comply with protocol requirements.\n* Age ≥18 years, male or female.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n* Confirmed diagnosis of immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), mixed autoimmune hemolytic anemia (mAIHA) or Evans Syndrome.\n* Relapsed or refractory autoimmune hemolytic anemia.\n\nExclusion Criteria:\n\n* Secondary ITP or AIHA caused by any reason. Subjects with positive autoimmune antibodies but without a clear diagnosis of any other autoimmune diseases are allowed to be enrolled.\n* Other types of AIHA or other types of cytopenia\n* History of critical diseases that, in the opinion of the investigator, may pose a risk to the safety of subjects or whose exacerbation during the study could compromise the efficacy or safety analysis of the results.\n* Received any treatment of anti-B Cell Maturation Antigen(BCMA) antibody.\n* Evaluated unsuitable to participant in this study by investigator.",{"count":280,"type":21},158,[24,53],"To evaluate the efficacy and safety of CM336 (BCMA\u002FCD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia",[284,28,285,286],"Autoimmune Cytopenia","Autoimmune Hemolytic Anemia","Evans Syndrome","2025-12-09",{"date":289,"type":34},"2025-12-17",{"date":291,"type":34},"2025-11-18",{"date":293,"type":21},"2028-11-18",{"name":295,"class":41},"Keymed Biosciences Co.Ltd",3,{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":303,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":316,"locationsCount":4},"100613615","national-multicenter-retrospective-real-world-study-on-the-treatment-status-of-newly-diagnosed-and-persistent-primary-immune-thrombocytopenia-itp-patients-100613615","NCT07268898","National Multicenter Retrospective Real-World Study on the Treatment Status of Newly Diagnosed and Persistent Primary Immune Thrombocytopenia (ITP) Patients","Inclusion Criteria:\n\n* Availability of traceable inpatient medical records;\n\nClinically diagnosed with newly diagnosed or persistent ITP (ITP disease course ≤12 months) between July 2021 and September 2025;\n\nBaseline platelet count \\\u003C30×10⁹\u002FL;\n\nAge ≥6 years;\n\nInclusion of patients regardless of ITP treatment status, encompassing those receiving any ITP-directed therapy (excluding emergency treatments such as platelet transfusion) and untreated patients (who have not received ITP-specific treatments including glucocorticoids, intravenous immunoglobulin, TPO-RAs, splenectomy, and rituximab).\n\nExclusion Criteria:\n\n\\-","6 Years",{"count":305,"type":21},500,"OBSERVATIONAL","This study is a nationwide, multicenter, retrospective, real-world, non-interventional (observational) investigation. It retrospectively collects data on treatment modalities and therapeutic responses in patients with newly diagnosed or persistent immune thrombocytopenia (ITP), documents disease progression in both treated and untreated patients, and records the treatment regimens selected by those receiving therapy. The study aims to observe and evaluate the current treatment landscape for newly diagnosed and persistent ITP patients, while also analyzing the efficacy and safety in the treated population. All patient treatments and disease management are solely based on routine clinical practice and are not influenced by this study.",[28],[310],"RWS","2025-11-25",{"date":313,"type":34},"2025-12-08",{"date":311,"type":21},{"date":33,"type":21},{"name":317,"class":147},"Institute of Hematology & Blood Diseases Hospital, China",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":107,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":124},"100608023","phase-1-an-exploratory-study-of-golidocitinib-in-adult-patients-with-itp-100608023","NCT07196163","An Exploratory Study of Golidocitinib in Adult Patients With ITP","An Exploratory Clinical Study of Golidocitinib in Adult Patients With Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n* Male and female participants between 18 and 80 years old.\n* Primary ITP for \\>3 months.\n* An average of two platelet counts (⩾ 7 days apart) of \\\u003C 30 × 10⁹\u002FL.\n* Have relapsed or treatment-resistant to previous ITP therapies, including corticosteroids and at least one other ITP therapy.\n* Have history of response to previous treatments.\n* Adequate hematologic, hepatic, and renal fuction.\n* Participants willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\n* Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia.\n* Previous or current therapy and comedications meet exclusion criteria.\n* Patients with major caridiovascular disease, active infetion, maligancy or uncontrolled systemic disease.\n* Women who are breast feeding.\n* History of hypersensitivity to sudy drug with a similar chemical structure or class.\n* Previously received JAK inhibitors.",{"count":326,"type":21},138,[24,53],"This is a multicenter clinical study to evaluate the safety and efficacy of golidocitinib in patients with primary immune thrombocytopenia (ITP). The study consists of two parts: Part A dose escalation and Part B dose expansion. Part A is designed to obtain the safety profile of golidocitinib in patients with ITP and the recommended dose for the randomized cohort in Part B. Part B is a randomized, double-blind, placebo-controlled study, and the primary objective of this part is to evaluate the preliminary efficacy of golidocitinib in patients with ITP.",[28],"2025-09-19",{"date":332,"type":34},"2025-09-29",{"date":334,"type":21},"2025-10-30",{"date":336,"type":21},"2029-10-30",{"name":338,"class":147},"Peking University People's Hospital",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":296},"100598013","phase-2-the-efficacy-and-safety-of-combined-teriflunomide-and-high-dose-dexamethasone-in-newly-diagnosed-primary-immune-thrombocytopenia-tempo-2-100598013","NCT07065968","The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)","Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial","Inclusion Criteria:\n\n1. Patients aged ≥18 years;\n2. Newly diagnosed, treatment naïve ITP patients;\n3. Patients with a platelet count \\\u003C30 x10\\^9\u002FL or a platelet count \\\u003C50 x10\\^9\u002FL with bleeding manifestations at the enrollment;\n4. Willing and able to sign written informed consent.\n\nExclusion Criteria:\n\n1. Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);\n2. Pre-existing acute or chronic liver disease, or ALT\u002FAST greater than 2 times the upper limit of normal (ULN);\n3. Severe cardiac, renal, hepatic, or respiratory insufficiency;\n4. Severe immunodeficiency;\n5. Pregnancy or lactation;\n6. Active or a history of malignancy;\n7. Active infection requiring systemic therapy;\n8. Myelodysplastic syndrome, aplastic anemia, or myelofibrosis;\n9. A known diagnosis of other autoimmune diseases;\n10. Patients who are deemed unsuitable for the study by the investigator.",{"count":347,"type":21},132,[53],"A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).",[28],"2025-08-31",{"date":353,"type":34},"2025-09-08",{"date":355,"type":34},"2025-08-19",{"date":357,"type":21},"2027-12-30",{"name":338,"class":147},{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":124},"100590894","anti-cd19bcma-car-gene-therapy-for-relapsedrefractory-immune-thrombocytopenia-100590894","NCT06973356","Anti CD19\u002FBCMA CAR Gene Therapy for Relapsed\u002FRefractory Immune Thrombocytopenia","An Exploratory Clinical Study of Anti-CD19\u002FBCMA CAR Gene Vector Injection (LCAR1901) for the Treatment of Relapsed and Refractory Immune Thrombocytopenia","LCAR1901","Inclusion Criteria:\n\n* 1\\. Age≥ 18 years old, regardless of gender. 2. Clinical diagnosis of primary immune thrombocytopenia for at least 6 months, platelet count \\\u003C 30×10\\^9\u002FL within 48 hours before participating in the study.\n\n  3\\. Positive anti-platelet glycoprotein autoantibodies (such as GPIIb\u002FIIIa). 4. Prior second-line ITP therapy (first-line treatment includes: corticosteroids or immunoglobulins; Second-line therapies include thrombopoietin receptor agonists (eg, eltrombopag, romiplostim) and\u002For rituximab, but are ineffective (platelet count \\\u003C 30×10\\^9\u002FL after treatment, or platelet count does not increase twice as much as baseline, or there is bleeding), or relapse after effective treatment (platelet count falls below 30×109\u002FL after effective treatment, or falls below baseline, or bleeding symptoms) or is difficult to maintain after discontinuation of TPO agonists.\n\n  5\\. Bone marrow examination shows megakaryocytosis or normal. 6. Basic normal functions of important organs:Echocardiography shows an ejection fraction of ≥50% and no significant abnormalities on ECG.Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥ 30 mL\u002Fmin.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN).Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤ 2.0× ULN (Gilbert's syndrome ≤3.0×ULN).Absolute lymphocyte count (ALC) ≥ 0.5×10\\^9\u002FL; Absolute neutrophil count (ANC) ≥1×10\\^9\u002FL; Hemoglobin (Hb) ≥ 60 g\u002FL; Platelet count ≥ 10×10\\^9\u002FL.Oxygen saturation \\> 92%.ECOG performance status ≤2 7. Males and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 1 year after the use of the study drug. Women of childbearing potential must have a negative blood pregnancy test at screening and prior to drug infusion and must not be breastfeeding.\n\nExclusion Criteria:\n\n* 1\\. Thrombocytopenia caused by myelodysplastic syndrome, early aplastic anemia, atypical aplastic anemia, thrombotic thrombocytopenic purpura, etc.\n\n  2\\. During the screening period, bone marrow examination showed myelofibrosis MF≥2 (European consensus scoring standard Thieleja 2005) or bone marrow examination showed the presence of a primary disease other than ITP that can lead to thrombocytopenia.\n\n  3\\. History of hypersensitivity to any component of the therapeutic medication. 4. Major organs: NYHA class III to IV congestive heart failure. Myocardial infarction or coronary artery bypass grafting (CABG) or coronary artery stent implantation within 6 months. Ventricular arrhythmias, or history of unexplained syncope (excluding vasovagal syncope or dehydration). History of severe non-ischemic cardiomyopathy.\n\n  5\\. Malignant disease within 3 years prior to screening, except for the following: malignant disease that has been curatively treated before enrollment and has no known active disease for 3 years ≥; or well-treated non-melanoma skin cancer with no evidence of disease.\n\n  6\\. Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months or currently requiring anticoagulation.\n\n  7\\. Participated in other interventional clinical studies within 1 month prior to screening.\n\n  8\\. Vaccination of live attenuated vaccine within 4 weeks prior to screening. 9. Stroke or seizure within 6 months prior to signing the ICF (excluding old lacunar cerebral infarction).\n\n  10\\. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer test exceeds the normal range; Hepatitis C virus (HCV) antibody is positive and the hepatitis C virus (HCV) RNA titer in peripheral blood exceeds the normal range; positive for human immunodeficiency virus (HIV) antibodies; Positive syphilis test.\n\n  11\\. Known history of bone marrow stem cell disease 12. Other conditions that the investigators consider unsuitable to participate in the study.",{"count":368,"type":21},18,[370],"NA","This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed and refractory immune thrombocytopenia. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19\u002FBCMA CAR gene vector injection",[28],[260,374],"Autoimmune diseases","2025-08-06",{"date":377,"type":34},"2025-08-08",{"date":379,"type":21},"2025-08-16",{"date":381,"type":21},"2029-06-30",{"name":383,"class":384},"Anhui Provincial Hospital","OTHER_GOV",{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":4},"100598338","longitudinal-cohort-study-on-immune-thrombocytopenia-complicated-with-acute-ischemic-stroke-100598338","NCT07070193","Longitudinal Cohort Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke","Retrospective and Prospective Longitudinal Observational Study on Immune Thrombocytopenia Complicated With Acute Ischemic Stroke","Inclusion Criteria:\n\n1. Diagnosed with immune thrombocytopenia, and subsequently identified patients with acute ischemic stroke.\n2. Since January 1, 2005, patients who received treatment at Peking University People's Hospital.\n\nExclusion Criteria:\n\n1. For any reason, such as the occurrence of severe mental disorders, the follow-up information may be unavailable;\n2. Patients deemed unsuitable for the study by the researchers.",{"count":305,"type":21},"Immune thrombocytopenia (ITP) is an acquired bleeding disorder mediated by immune-related platelet destruction and impaired platelet production. Immune thrombocytopenia may increase the risk of cerebral infarction and represents a relatively uncommon etiology of acute ischemic stroke. This disease is associated with high disability and mortality rates, poses significant therapeutic challenges, and constitutes a serious threat to human health. Therefore, research on the diagnosis, treatment, and prognosis of ITP combined with acute ischemic stroke is of great significance for improving patients' quality of life and survival outcomes. However, most current hematologic cohort studies are based on single-center or limited multicenter sample sizes, lacking comprehensive and large-scale prospective cohort studies. Our center plans to conduct a large-sample, combined retrospective and prospective longitudinal cohort study. This study will register patients' basic information and diagnosis, follow up with patients through questionnaires, telephone calls, video consultations, online platforms, and in-person visits to record treatment and comorbidity data, collect prognostic information, and retrieve hospitalization and outpatient costs through medical record systems. The study aims to provide comprehensive data on the incidence, treatment, prognosis, and healthcare costs of ITP patients with acute ischemic stroke in China.",[28,395],"Acute Ischemic Stroke",[397,395],"Immune Thrombocytopenia","2025-07-08",{"date":400,"type":34},"2025-07-17",{"date":402,"type":21},"2025-07-10",{"date":404,"type":21},"2036-12-31",{"name":338,"class":147},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":422,"leadSponsor":423,"locationsCount":124},"100598202","longitudinal-observational-study-on-immune-thrombocytopenia-100598202","NCT07068425","Longitudinal Observational Study on Immune Thrombocytopenia","Retrospective and Prospective Longitudinal Observational Study on Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Patients with confirmed diagnosis of ITP\n2. Patients treated at Peking University People's Hospital since January 1, 2005\n\nExclusion Criteria:\n\n1. Any condition that may render follow-up data unreliable, including but not limited to severe psychiatric disorders\"\n2. Patients deemed ineligible for the study by investigators\"",{"count":414,"type":21},2000,"Immune Thrombocytopenia (ITP) is a bleeding disorder characterized by immune-mediated destruction and\u002For impaired production of platelets, leading to clinical manifestations such as petechiae, purpura, mucosal bleeding, and in severe cases, life-threatening visceral or intracranial hemorrhage. Research on the diagnosis, treatment, and prognosis of ITP is critical for improving patient outcomes and quality of life. However, most existing hematologic cohort studies are limited to single-center or small multicenter samples, lacking comprehensive, large-scale prospective investigations.\n\nTo address this gap, our center plans to conduct a large-sample, combined retrospective and prospective longitudinal observational cohort study of ITP patients. The study will enroll patients to collect baseline demographic and diagnostic data, followed by longitudinal follow-up via questionnaires, telephone interviews, video consultations, online platforms, and in-person visits. Key variables including treatment regimens, comorbidities, and prognostic outcomes will be systematically recorded. Additionally, hospitalization and outpatient expenditure data will be extracted from electronic medical records.\n\nThis study aims to provide high-quality real-world evidence on the epidemiology, treatment patterns, clinical outcomes, and healthcare costs of ITP patients in China, ultimately informing clinical decision-making and health policy.",[28],[397],"2025-07-06",{"date":420,"type":34},"2025-07-16",{"date":402,"type":21},{"date":404,"type":21},{"name":338,"class":147},{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":124},"100597383","phase-2-iguratimod-plus-low-dose-rituximab-vs-low-dose-rituximab-in-corticosteroid-resistant-or-relapsed-itp-100597383","NCT07057778","Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP","Inclusion Criteria:\n\n* ITP confirmed by excluding other supervened causes of thrombocytopenia;\n* Platelet count of less than 30×10\\^9\u002FL at enrollment;\n* Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;\n\nExclusion Criteria:\n\n* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);\n* Congestive heart failure;\n* Severe arrhythmia;\n* Nursing or pregnant women;\n* Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria;\n* Creatinine or serum bilirubin levels each 1•5 times or more than the normal range;\n* Active or previous malignancy;\n* Patients with other diseases were undergoing treatment with immunosuppressants;\n* Patients with ITP had received rituximab;","70 Years",{"count":432,"type":21},120,[53],"Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant\u002Frelapsed ITP.",[28],[437],"Iguratimod",{"date":402,"type":34},{"date":440,"type":21},"2025-07-01",{"date":442,"type":21},"2027-07-01",{"name":338,"class":147},{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":16,"sex":17,"minAge":451,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":4},"100596480","level-of-serum-lactate-dehydrogenase-in-immune-thrombocytopenia-100596480","NCT07046013","Level of Serum Lactate Dehydrogenase in Immune Thrombocytopenia","Relation Between Serum Lactate Dehydrogenase and Immune Thrombocytopenia","Inclusion Criteria:\n\n* Thrombocytopenia patients at the time of diagnosis.\n\nExclusion Criteria:\n\n* bone fractures \\_ bone diseases\\_ malignancy","16 Years",{"count":453,"type":21},40,"Assessment of relation between serum lactate dehydrogenase and immune thrombocytopenia",[28],"2025-06-22",{"date":440,"type":34},{"date":459,"type":21},"2025-08",{"date":461,"type":21},"2027-07",{"name":463,"class":147},"Sohag University",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":124},"100581679","phase-1-a-phase-12-study-of-esg206-in-patients-with-primary-immune-thrombocytopenia-100581679","NCT06853444","A Phase 1\u002F2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia","A Phase 1\u002F2 Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n* 1\\. Willing and able to provide written informed consent for this trial.\n* 2\\. Male or female, age ≥ 18 years on the day of signing the informed consent form.\n* 3\\. Diagnosed with primary immune thrombocytopenia (ITP), and having received treatment of corticosteroids ± intravenous immunoglobulin (IVIG) in the past.\n* 4\\. At the time of the last ITP treatment, loss of response, insufficient response, no response or intolerance occurred.\n* 5\\. At screening, Platelet Count revealed \\\u003C 30 \\* 10\\^9\u002FL twice (with an interval of at least 24 hours between the two tests).\n* 6\\. Subjects must have adequate organ function.\n* 7\\. The World Health Organization (WHO) bleeding scale is 0-1.\n* 8\\. Fertile men and women of reproductive age must agree to use effective contraception from the time they sign the informed consent until 180 days after the last dose of the trial drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Women who are fertile must have a pregnancy test within 7 days before the trial drug is first given and the result should be negative.\n\nExclusion Criteria:\n\n* 1\\. Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia, or the patient has multiple immune cytopenias.\n* 2\\. Previously received B-cell depletion therapy (e.g., rituximab, Ianalumab, etc.).\n* 3\\. Received platelet transfusion or whole blood transfusion, plasma exchange, or any other rescue treatment within 14 days before the first administration of the trial drug.\n* 4\\. Participated in other investigational drug clinical studies within 4 weeks before the first administration of the investigational drug or within 5 half-lives of the investigational drug received (whichever is longer).\n* 5\\. Underwent splenectomy within 12 weeks before the first administration of the investigational drug.\n* 6\\. Received traditional Chinese medicine treatment with definite platelet-raising effects within 1 week before the first administration of the trial drug.\n* 7\\. Underwent major surgery within 4 weeks before the first administration of the investigational drug or needs to undergo major elective surgery during the study period.\n* 8\\. Diagnosed with Evans syndrome or any other cytopenia (patients with mild anemia related to bleeding or iron deficiency are eligible for inclusion in the study).\n* 9\\. Patients with current or previous life-threatening bleeding related to thrombocytopenia.\n* 10\\. Patients with concurrent coagulation disorders and\u002For receiving antiplatelet or anticoagulant therapy (e.g., warfarin, clopidogrel, or new oral anticoagulants), except for low-dose acetylsalicylate (≤150 mg\u002Fday).\n* 11\\. Patients with deep vein thrombosis or arterial thrombosis within 6 months before enrollment, and\u002For with risk factors for hereditary thrombophilia.\n* 12\\. Patients with a history of severe cardiovascular and pulmonary diseases.\n* 13\\. Patients with uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n* 14\\. Patients with human immunodeficiency virus (HIV) infection, or active hepatitis B or C, or liver cirrhosis.\n* 15\\. Patients with active viral, bacterial, or other infections requiring systemic treatment during the screening period, or with a history of clinically significant recurrent infections (e.g., bacterial infection with capsule). Patients with a history of tuberculosis (TB) or latent TB who have undergone anti-TB treatment may be eligible for inclusion.\n* 16\\. Patients who received live or attenuated live vaccines within 4 weeks before the first administration of the investigational drug.\n* 17\\. Patients with a history of or current malignant tumors, except for cured non-melanoma skin cancer, carcinoma in situ (e.g., cervical cancer, breast cancer, bladder cancer, prostate cancer), and cancers that have been in complete remission for at least 3 years without evidence of recurrence.\n* 18\\. Patients with any severe and\u002For unstable pre-existing medical, mental, or other conditions that the investigator deems may interfere with the patient's efficacy, safety, informed consent, or compliance with the study procedures.\n* 19\\. Patients with known immediate or delayed hypersensitivity reactions to monoclonal antibodies or components of the trial drug, or with a history of allergic constitution.\n* 20\\. Pregnant or lactating women.\n* 21\\. Patients who are unwilling or unable to follow the protocol procedures.",{"count":472,"type":21},84,[24,53],"This is a multicenter, open-label Phase1\u002F2 study aimed at evaluating the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ESG206. The study will be conducted in patients with primary immune thrombocytopenia.",[28],"2025-05-13",{"date":478,"type":34},"2025-05-16",{"date":480,"type":34},"2025-05-08",{"date":482,"type":21},"2027-04-30",{"name":484,"class":41},"Shanghai Escugen Biotechnology Co., Ltd",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":124},"100588633","phase-1-a-clinical-study-of-yts109-cell-in-rr-systemic-lupus-erythematosus-100588633","NCT06943937","A Clinical Study of YTS109 Cell in R\u002FR Systemic Lupus Erythematosus","An Exploratory Clinical Study of YTS109 Cell in Subjects With Refractory Disease Systemic Lupus Erythematosus","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Meet the EULAR\u002FACR 2019 SLE Classification Criteri:\n\nCohort 1: Refractory Lupus Nephritis: Defined as failure to achieve remission after treatment with corticosteroids and ≥2 immunosuppressants (e.g., CTX, tacrolimus, MMF, cyclosporine) and\u002For biologics, with urine protein\u002Fcreatinine ratio (UPCR ≥1.0 g\u002Fg) , and renal pathology requirement scriteria: ISN\u002FRPS 2003 Class III\u002FIV proliferative lupus nephritis (or combined with type V features) , with ≤50% glomerulosclerosis.\n\nCohort 2: Refractory Immune Thrombocytopenia: Requires treatment failure with: Failed treatment with at least 1 course of MP shock (1g for 3 days) or high- dose glucocorticosteroids (1mg\u002Fkg\u002Fd equivalent dose of glucocorticosteroids) in combination with 1 or more immunosuppressive agents. At least 2 consecutive routine blood tests for platelets less than 50×10\\^9\u002FL and \\>30×10\\^9\u002FL were performed prior to enrolment. other non-SLE causes of thrombocytopenia, such as infections, myelosuppression and hypersplenism, were excluded.\n\n3\\. Essential Organ Function Criteria:\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use).\n\n   Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL\n\n   ≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n5\\. Voluntary participation with signed informed consent and compliance.\n\nExclusions Criteria:\n\nSubjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Severe drug allergies or hypersensitivity.\n2. Uncontrolled\u002Funtreated infections (fungal, bacterial, viral, etc.).\n3. CNS disorders (exceptions: epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis).\n4. Heart failure intolerance.\n5. Congenital immunoglobulin deficiency.\n6. Malignancy within 5 years (exceptions: localized cancers with negligible metastasis risk).\n7. End-stage renal failure.\n8. Subjects positive for: HBsAg \u002F HBcAb with HBV DNA \\> detection limit; HCV Ab + HCV RNA; HIV Ab; Syphilis test.\n9. Deep vein thrombosis\u002Fpulmonary embolism within 6 months pre- screening.\n10. Severe mental illness\u002Fcognitive impairment.\n11. Participation in other clinical trials within 3 months pre-screening.\n12. Use of immunosuppressants (within 5 half-lives) or biologics (within 4 weeks) pre-screening.\n13. Pregnancy\u002Fbreastfeeding or planned conception.\n14. Other researcher-determined ineligibility.","65 Years",{"count":494,"type":21},36,[24],"This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (1×10⁶-2×10⁶ cells\u002Fkg). The primary endpoint is observations of types, severity, and frequency of dose-limiting toxicities (DLTs) and adverse events (AEs). Secondary endpoints include the complete renal response (CRR) rate at week 12 in LN, and proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP. This single-arm, open-label trial will enroll patients across Beijing GoBroad Hospital in China.",[498,28],"Lupus Nephritis (LN)",{"date":476,"type":34},{"date":501,"type":34},"2025-04-16",{"date":503,"type":21},"2027-04-25",{"name":505,"class":41},"China Immunotech (Beijing) Biotechnology Co., Ltd.",{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":124},"100577539","phase-2-an-open-exploratory-clinical-study-of-cm336-in-the-treatment-of-immune-thrombocytopenia-100577539","NCT06799611","An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia","An Open, Exploratory Clinical Study to Assess Safety and Efficacy of BCMA-CD3 Bispecific Antibody CM336 in the Treatment of Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age 18 and above, male or female;\n* Conform to the diagnostic criteria of persistent or chronic immune thrombocytopenia (ITP);\n* Failure of previous glucocorticoid therapy;\n* In the second-line treatment phase, eligible subjects must meet any of the following criteria: (1) Demonstrate no response to treatment with at least one thrombopoietin receptor agonist (including but not limited to recombinant human thrombopoietin \\[rhTPO\\], eltrombopag, hetrombopag, avatrombopag, or romiplostim); Fail to achieve sustained response (manifested as non-response, loss of response, or disease relapse) following anti-CD20 monoclonal antibody therapy (e.g., rituximab) or anti-CD38 monoclonal antibody therapy; (2) Exhibit no therapeutic response or experience disease relapse after splenectomy.\n* The platelet count was \\\u003C30×109\u002FL within 48 hours before the first administration;\n* ECOG physical state score ≤ 2 points;\n* Patients receiving maintenance treatment (including corticosteroids (less than or equal to 20mg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration;\n* Signed and dated written informed consent;\n\nExclusion Criteria:\n\n* Received any treatment of anti-BCMA antibody drug;\n* Accompanied by autoimmune hemolytic anemia, or various secondary and hereditary thrombocytopenia;\n* History of any thrombotic or embolic events in the 12 months prior to the first dose or accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc;\n* Participated in any other study drug or exposure to other study drugs within 4 weeks or 5 half-lives before the first dose (whichever is longer);\n* Use of anticoagulants or any drug with antiplatelet effects (such as aspirin) within 3 weeks before the first dose;\n* Treatment with ITP (methylprednisolone, platelet, gamma-globulin infusion or TPO receptor agonist therapy) within 2 weeks before the first dose;\n* Splenectomy was performed within 6 months before the first dose;\n* Patients who received azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc., within 4 weeks prior to the first dose; or received treatments such as CD20 monoclonal antibodies (e.g., rituximab), CD38 monoclonal antibodies, cyclophosphamide, or vindesine within 3 months prior to the first dose；\n* Received a live vaccine within 4 weeks before the first dose, or planned to receive any live vaccine during the clinical trial;\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;\n* Other serious diseases that may limit the subject's participation in this trial (such as diabetes; Hepatic and renal insufficiency; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);\n* Patients with malignant tumors within 5 years before the screening;\n* A history of severe recurrent or chronic infection;\n* A known or suspected history of immunosuppression, including a history of invasive opportunistic infections;\n* Clinically significant laboratory abnormalities at the time of screening;\n* HIV antibody or syphilis antibody positive;\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C; Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients;\n* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;\n* Patients whose symptoms of toxicity from pre-trial treatment have not resolved;\n* Any other ineligibility for subjects in the study was assessed by the investigator.",{"count":198,"type":21},[53],"To evaluate the efficacy and safety of CM336 in the treatment of refractory adult primary immune thrombocytopenia",[28,517],"Treatment","2025-03-11",{"date":520,"type":34},"2025-03-13",{"date":522,"type":34},"2025-03-03",{"date":524,"type":21},"2027-01-31",{"name":317,"class":147},{"id":527,"slug":528,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":107,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":124},"100436871","phase-3-igiv-plus-prednisone-vs-high-dose-dexamethasone-for-itp-100436871","NCT04968899","IgIV Plus Prednisone vs High-dose Dexamethasone for ITP","Intravenous Immunoglobulin Plus Oral Prednisone or High-dose Dexamethasone, for Adults With Immune Thrombocytopenia (ITP) With Moderate and Severe Bleeding: a Randomized, Multicentre Trial","IVIORDEX","Inclusion Criteria:\n\n* Age ≥ 18 years ≤ 80 years\n* Diagnosis of ITP whatever the duration of the disease (newly diagnosed or relapsed) according to the standard definition\n* Platelet count ≤ 20 x 109\u002FL\n* Any cutaneous and\u002For any mucosal bleeding manifestations\n* Affiliated to a social security regime\n* Written consent from patient\n\nExclusion Criteria:\n\n* Symptomatic COVID-19 disease\n* Life-threatening bleeding defined as Intracranial hemorrhage and\u002For active organ bleeding (GI tract, urinary tract or menorrhagia with at least a 2 g\u002Fdl decrease of hemoglobin value from baseline).\n* Ongoing anticoagulation treatment (Therapeutic Low molecular weight heparins (LMWHs), direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs))\n* Previous non-response to IVIg or DEX\n* Treatment with prednisone (1 mg\u002Fkg per day) for more than 3 days\n* Any, contraindications to the prescribed Ig IV or prednisone patent medicine and to Neofordex®\n* Ongoing severe infection\n* Severe Renal insufficiency (DFG \\\u003C 45 ml.min.1.73m2)\n* Severe Cardiac insufficiency (FEVG \\\u003C 30 %)\n* Ongoing viral infection (uncontrolled HIV, Viral hepatitis, herpes, varicella, zona).\n* Uncontrolled diabetes (Acido-cetosis)\n* Psychotic state not yet controlled by treatment\n* Inability or refusal to understand or refusal to sign the informed consent from study participation\n* Persons deprived of their liberty by judicial or administrative decision,\n* Persons under legal protection (guardianship, curatorship)\n* Pregnant or breastfeeding woman or ineffective contraception\n* Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants.",{"count":535,"type":21},272,[81],"ITP patients with low platelet count and active bleeding symptoms are at risk of life-threatening bleeding and therefore require a treatment with a rapid effect, reliable, and sustained. The combination of intravenous immunoglobulin (IVIg) and prednisone (1 mg\u002Fkg per day), is more rapidly and more frequently effective than high dose methylprednisolone to increase the platelet count. This combination is therefore usually given in patients with platelets count \\\u003C 20 x 109\u002FL and moderate to severe bleeding manifestations. Based on common practice in France and on French ITP guidelines, on average 50 % of patients with ITP and profound thrombocytopenia do actually receive IVIg (mostly during the initial phase of the disease) corresponding to approximately 1,500 ITP patients per year in France.\n\nWhereas IVIg is usually well tolerated, renal insufficiency and congestive heart failure may occur, moreover IVIg are costly and non-easily available with supply difficulties in many countries including France.\n\nHigh dose dexamethasone (DXM) (ie: 40 mg\u002Fd for 4 days) has recently emerged as a promising treatment for ITP. One recent meta-analysis as well as a controlled prospective trial suggest that the initial overall response was higher (\\> 80 %) and the time to response was shorter with dexamethasone (DXM) 40 mg\u002Fd given for 4 days compared to standard prednisone.\n\nThe investigators hypothesize that DXM could be a reasonable non-inferior alternative to IVIg, more convenient for patients with less adverse events and economically cost-effective for patients with moderate and severe bleeding manifestations.",[28],[540,541,542,543],"Immune thrombocytopenia (ITP)","Dexamethasone","IntraVenous Immunoglobulin","Prednisone","2023-09-08",{"date":546,"type":34},"2023-09-11",{"date":548,"type":34},"2022-04-07",{"date":550,"type":21},"2026-10-09",{"name":552,"class":147},"Assistance Publique - Hôpitaux de Paris"]