[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-immune-thrombocytopenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-immune-thrombocytopenia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,78,103,126,151,173,195,222,245,267],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100053651","phase-3-a-study-of-romiplostim-plus-prednisolone-vs-prednisolone-alone-for-the-treatment-of-previously-untreated-primary-immune-thrombocytopenia-itp-100053651",false,"NCT07700238","A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)","A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP).","ROMISTER","Inclusion Criteria:\n\n* Age ≥18 years or adult legal age within country if older than 18 years.\n* Diagnosis of primary ITP according to the 2019 International Consensus (ICR) that is previously untreated and requires treatment.\n\n  * Note: The investigator should ensure that the diagnosis of primary ITP is established by excluding other causes of isolated thrombocytopenia, as outlined in the 2019 ICR, which states that the diagnosis of primary ITP is principally based on the exclusion of other causes of isolated thrombocytopenia.\n  * Note: If emergency treatment is necessary, platelet count performed before emergency can be used for study inclusion.\n  * Note: Emergency ITP treatment with any thrombopoietin receptor agonists (TPO-RAs), or splenectomy is not allowed.\n* Platelet count \\\u003C 30 × 10\\^9\u002FL or Platelet count \\\u003C 50× 10\\^9\u002FL with clinically significant bleeding before any medical intervention.\n\nExclusion Criteria:\n\n* Life-threatening bleeding at randomization.\n* Known sensitivity or intolerance to any of the products to be administered during study (eg, uncontrolled diabetes) or to any Escherichia coli-derived product (eg, filgrastim, pegfilgrastim, certain insulins).\n* Uncontrolled hypertension before randomization.\n* Abnormal hepatic or renal function at screening.\n* History of total splenectomy.\n* Use of concurrent anticoagulation therapy and\u002For antiplatelet therapy.\n* Need for nonsteroidal anti-inflammatory drugs (NSAIDs) use and use of NSAIDs within 7 days before randomization.\n* Venous or arterial thrombotic event within 3 or 6 months, respectively, before randomization.\n* Other protocol-defined Inclusion\u002FExclusion may apply.","ALL","18 Years","100 Years",{"count":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).",[28],"Primary Immune Thrombocytopenia",[30],"Adult ITP","NOT_YET_RECRUITING","2026-07-07",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":22},"2026-07-20",{"date":39,"type":22},"2029-09-14",{"name":41,"class":42},"Amgen","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100595974","phase-2-study-of-ianalumab-in-adults-with-primary-immune-thrombocytopenia-itp-and-warm-antibody-autoimmune-hemolytic-anemia-waiha-who-have-previously-benefited-from-ianalumab-100595974","NCT07039422","Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab","A Phase 2 Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab.","VAY RE-HIT","Inclusion Criteria:\n\n* Signed informed consent obtained prior to participation in the study.\n* Male or female participants aged 18 years and older on the day of signing informed consent\n\nPrimary ITP patients:\n\n* Previously enrolled and treated either with ianalumab\u002Fplacebo in addition to first-line corticosteroids on protocol CVAY736I12301 or with ianalumab\u002Fplacebo in addition to eltrombopag in the second line on protocol CVAY736Q12301, and who experienced treatment failure (TF) by parent trial definition ≥ 2 years after the last infusion of ianalumab\u002Fplacebo\n* Rescue medication and\u002For bridging therapy are allowed to be started within the 28 days prior to screening; platelet count results obtained prior to the start of the therapy must be used to assess eligibility and have to be collected within 30 days prior to screening\n\nFor Primary or Secondary wAIHA patients:\n\n* Previously documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA, previously enrolled and treated with ianalumab\u002Fplacebo in blinded cohort or placebo followed by crossover to open label ianalumab in protocol CVAY736O12301, having experienced durable response lasting beyond 2 years from the last infusion of ianalumab\u002Fplacebo in blinded cohorts or a durable response beyond week 20 from last dose of first course of ianalumab in the crossover arm.\n* Relapsed wAIHA with hemoglobin concentration ≥5 g\u002FdL and \\\u003C10 g\u002FdL and presence of symptoms related to anemia during screening or within 14 days before screening window or within 28 days before screening window if rescue medication\u002Fbridging therapy has been initiated.\n* Rescue medication and\u002For bridging therapy are allowed to be started during the screening and within 28 days prior to screening; hemoglobin level result for eligibility assessment needs to be obtained prior to the start of the treatment within 30 days prior to screening\n* Supportive care is allowed in the case the participant received it in the parent trial when the relapse occurred and has remained stable at least 4 weeks prior screening\n\nExclusion Criteria:\n\n* Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA), except for grade 1 anemia due to blood loss or iron deficiency.\n* Secondary wAIHA with BM involvement for wAIHA patients\n* Current life-threatening bleeding or history of life-threatening bleeding due to thrombocytopenia\n* Therapy for ITP or wAIHA other than ianalumab\u002Fplacebo, bridging\u002Frescue therapies and supportive care prior to the beginning of the screening window\n* After primary analysis of each respective parent trial, participants whose treatment was unblinded and who received placebo only will be excluded.\n* ITP participants only: Participants with concurrent coagulation disorders and\u002For receiving anti-platelet or anti-coagulant medication except for low dose of acetylsalicylic acid (≤150 mg per day)\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":52,"type":22},60,[54],"PHASE2","This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).",[28,57],"Warm Autoimmune Hemolytic Anemia",[59,60,61,62,63,64,65,66],"Primary Immune Thrombocytopenia (ITP)","ITP","Warm Autoimmune Hemolytic Anemia (wAIHA)","wAIHA","VAY736","Ianalumab","B-cell depletion","B-cell Activating Factor Receptor (BAFF-R) blockade","RECRUITING","2026-06-04",{"date":70,"type":35},"2026-06-08",{"date":72,"type":22},"2026-06-26",{"date":74,"type":22},"2030-08-30",{"name":76,"class":42},"Novartis Pharmaceuticals",22,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100444700","phase-2-safety-and-efficacy-study-of-pf-06835375-in-primary-immune-thrombocytopenia-100444700","NCT05070845","Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia","AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA","Inclusion Criteria:\n\n* Diagnosis of Primary ITP. Ongoing ITP (platelet counts \\\u003C50 x 109\u002FL) \\[No severe bleeding within 1 month or during screening\\] AND Persistent ITP (3 to 12 months) or Chronic ITP \\>12 months\n\nExclusion Criteria:\n\n* Bleeding event according to the WHO grading scale ≥2 occurring ≤4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening\n* Splenectomy within 3 months of randomization or planned during the study duration.","70 Years",{"count":87,"type":22},91,[54],"This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\\>3 months and ≤12 months), or chronic (\\>12 months) ITP",[28],[60,92],"platelets","2026-05-11",{"date":95,"type":35},"2026-05-12",{"date":97,"type":35},"2022-02-02",{"date":99,"type":22},"2028-08-02",{"name":101,"class":42},"Pfizer",31,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":125,"locationsCount":4},"100611723","managed-access-programs-for-vay736-ianalumab-100611723","NCT07244289","Managed Access Programs for VAY736, Ianalumab","Inclusion Criteria:\n\n1. An independent request was received from a licensed physician.\n2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.\n3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.\n4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).\n6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.\n7. Managed Access provision is allowed per local laws\u002Fregulations.","EXPANDED_ACCESS","The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab",[28,112],"Sjögren's Syndrome",[114,115,63,116,59,117,118,119,120],"MAP","Managed Access Program","ianalumab","Sjögren's Syndrome (SjD)","Expanded Access","Early Access","Compassionate use","AVAILABLE","2026-03-19",{"date":124,"type":35},"2026-03-23",{"name":76,"class":42},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":150},"100524350","longitudinal-cohort-of-pediatric-primary-immune-thrombocytopenia-itp-100524350","NCT06107582","Longitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP)","Clinical Characteristics, Prognosis and Prognostic Model of Pediatric Immune Thrombocytopenia: a Prospective, Multicenter, Observational Cohort Study","Inclusion Criteria:\n\n* Age 6-17 years old (including both ends), male and female;\n* Diagnosis of ITP.\n\nExclusion Criteria:\n\n* Secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.;\n* The expected follow-up period is less than 3 months.","6 Years","17 Years",{"count":136,"type":22},500,"OBSERVATIONAL","Immune thrombocytopenic purpura (ITP) is a kind of rare childhood disease that involve autoimmune destruction of platelets.The current Pediatric ITP cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in pediatric ITP. The purpose of this study is to analyze the clinical characteristics of Pediatric ITP, the treatment methods, prognosis and prognostic model of these patients in China.",[28],"2026-02-09",{"date":142,"type":35},"2026-02-11",{"date":144,"type":35},"2023-11-01",{"date":146,"type":22},"2036-12",{"name":148,"class":149},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100599380","phase-2-a-study-on-the-safety-and-efficacy-of-tqb3473-tablets-in-the-treatment-of-persistent-or-chronic-primary-immune-thrombocytopenia-itp-in-adults-100599380","NCT07083739","A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults","Phase II Clinical Trial on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults","Inclusion Criteria:\n\nCohort 1 :\n\n* Voluntarily participate in this study with signed informed consent form (ICF) and demonstrated good compliance.\n* Age ≥18 years (calculated from the date of ICF signing); no gender restrictions; Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Clinically stable condition with WHO bleeding scale score 0-1, and investigator assessment indicates no need for emergency treatment within the next 2 weeks.\n* No increase in the type, dosage, or frequency of concomitant ITP medications compared to the TQB3473-III-01 study regimen.\n* Previous participation in the TQB3473-III-01 study with either: Sustained platelet count \\\u003C30×10⁹\u002FL during the 12-week pre-randomization period (\\\u003C50×10⁹\u002FL if emergency treatment was received), or completion of 24-week double-blind treatment with investigator-confirmed benefit-risk assessment favoring continued therapy.\n* Adequate major organ function as defined by protocol criteria.\n* For women of childbearing potential: Must agree to use highly effective contraception from screening through 6 months after treatment completion and refrain from oocyte donation for reproductive purposes during this period; must not be breastfeeding with negative serum\u002Furine pregnancy test within 7 days prior to enrollment. For male participants with fertile partners: Must agree to use effective contraception during the study and for 6 months thereafter.\n\nCohort 2 ：\n\n* Subjects voluntarily participate in this study upon signing the Informed Consent Form (ICF) with demonstrated compliance.\n* Age ≥ 18 years (calculated from signing date of ICF); No gender restrictions; ECOG performance status score 0-1.\n* Confirmed diagnosis of primary ITP \\>3 months prior to enrollment.\n* Clinically stable condition with WHO bleeding score 0-1, no major bleeding episodes within 4 weeks pre-randomization, and investigators confirm no anticipated need for emergency treatment within 2 weeks.\n* Meeting all platelet criteria: Mean platelet count \\\u003C30×10⁹\u002FL (no single value \\>35×10⁹\u002FL) from ≥2 independent measurements (≥3 days apart) within 7 days pre-enrollment Confirmed platelet count \\\u003C30×10⁹\u002FL within 24 hours before enrollment.\n* Documented failure or relapse after ≥1 prior standard ITP therapy.\n* Adequate function of major organs per protocol definitions.\n* Permitted ≤1 concurrent ITP treatment (any class), provided: Stable dose maintained for ≥4 weeks prior to enrollment (≥2 weeks for corticosteroids)\n* For women of childbearing potential: Must agree to use highly effective contraception from screening through 6 months after treatment completion and refrain from oocyte donation for reproductive purposes during this period; must not be breastfeeding with negative serum\u002Furine pregnancy test within 7 days prior to enrollment. For male participants with fertile partners: Must agree to use effective contraception during the study and for 6 months thereafter.\n\nExclusion Criteria:\n\n* Cohort 1 :\n\n  1. Due to reasons other than lack of efficacy, receiving TQB3473-III-01 study treatment for less than 12 weeks.\n  2. Hepatitis B Virus (HBV) DNA or Hepatitis C Virus (HCV) RNA detection values exceeding the upper limit of normal or decompensated cirrhosis\n  3. Previous intracranial hemorrhage or severe bleeding of other important organs (≥ CTC AE grade 3), or symptomatic gastrointestinal bleeding (such as vomiting blood, black stool, etc., except for asymptomatic and asymptomatic \"occult blood test positive\" and hemorrhoids) within the 6 months before enrollment.\n  4. Suffering from major cardiovascular and cerebrovascular diseases.\n  5. There are multiple factors that can affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction.\n  6. Those who have received major surgical treatment, significant traumatic injury, or are expected to undergo major elective surgery during the study treatment period within the 4 weeks prior to enrollment\n  7. Uncontrolled significant active infections (such as sepsis, pneumonia, or abscess), or severe infections within the 12 weeks prior to enrollment (resulting in hospitalization or requiring antibiotic treatment).\n  8. Vaccination was administered within 8 weeks prior to enrollment, or planned during the study period.\n  9. Received blood transfusions or blood products within 2 weeks prior to enrollment (excluding IVIg used for emergency treatment).\n  10. Take strong CYP3A inhibitors or inducers (3 weeks for Forsythia suspensa) for 2 weeks or 5 half lives (whichever is longer) before enrollment.\n  11. Long term\u002Fcontinuous treatment with drugs that affect platelet function (including but not limited to aspirin, clopidogrel, ticagrelor, NSAIDs, etc.) or anticoagulant therapy is required.\n  12. Allergic constitution or history of severe allergies, or known allergies to the components of the investigational drug excipients.\n  13. There are clear neurological or mental disorders, or serious psychological or mental abnormalities.\n  14. Alcoholic or drug abusers.\n  15. According to the researcher's perspective, other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study or interfere with the interpretation of the research results.\n  16. It is estimated that the patient's compliance in participating in this clinical study is insufficient.\n\nCohort 2：\n\n* There is evidence to suggest the presence of secondary causes of ITP in the subjects, or immune cell depletion of two or more lineages, such as Evans syndrome;\n* Past or current presence of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other malignant hematological diseases.\n* Have had or currently have malignant tumors within the past 3 years. The following two situations can be included in the group: other malignant tumors treated with a single surgery, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\\].\n* HBV DNA or HCV RNA detection values exceeding the upper limit of normal or decompensated cirrhosis.\n* Previous intracranial hemorrhage or severe (≥ Common Terminology Criteria (CTC) AE grade 3) bleeding of other important organs, or symptomatic gastrointestinal bleeding (such as vomiting blood, black stool, etc., except for asymptomatic and asymptomatic \"occult blood test positive\" and hemorrhoids) within the 6 months before enrollment.\n* Suffering from major cardiovascular and cerebrovascular diseases.\n* There are multiple factors that can affect oral medication, such as inability to swallow, active gastric ulcers, major gastrointestinal surgeries, chronic diarrhea, and intestinal obstruction.\n* ITP related symptoms and treatment:\n\n  * Received ITP emergency treatment within 2 weeks prior to enrollment;\n  * Received platelet transfusion within 2 weeks prior to enrollment;\n  * Received immunoglobulin or traditional Chinese medicine treatment within 2 weeks before enrollment;\n  * Used rituximab or other anti-Cluster of Differentiation 20 (CD20) drugs within 14 weeks prior to enrollment;\n  * Received splenectomy within 12 weeks prior to enrollment;\n  * Individuals who have received glucocorticoids within the 2 weeks prior to enrollment, or have received thrombopoietin drugs (rhTPO, eltrombopag, hetrombopag, avatrombopag, romiplostim), immunomodulators (azathioprine, cyclosporine A, mycophenolate mofetil), chemotherapy drugs (decitabine, vinblastine), danazol, etc. within the 4 weeks prior to enrollment, except for those who meet the inclusion criteria 8 and are allowed to undergo concomitant treatment.\n* Adverse reactions from previous treatments that have not recovered to ≤ CTCAE grade 1, as well as non clinically significant and asymptomatic laboratory abnormalities that have been determined by researchers to pose no safety risks, are excluded.\n* Patients who have received major surgical treatment, significant traumatic injury, or are expected to undergo major elective surgery during the study treatment period within the 4 weeks prior to enrollment (major surgery is defined as surgery at level 3 or above in the National Surgical Classification Catalogue 2022 edition).\n* Vaccination was administered within 8 weeks prior to enrollment, or planned during the study period.\n* Uncontrolled significant active infections (such as sepsis, pneumonia, or abscess), or severe infections within the 12 weeks prior to enrollment (resulting in hospitalization or requiring antibiotic treatment).\n* Received blood transfusions or blood products within 2 weeks prior to enrollment (excluding intravenous immunoglobulin (IVIg) used for emergency treatment).\n* Take strong Cytochrome P450 3A (CYP3A) inhibitors or inducers (3 weeks for Forsythia suspensa) for 2 weeks or 5 half lives (whichever is longer) before enrollment.\n* Participants who have participated in and used other clinical trial drugs within 4 weeks prior to enrollment.\n* Long term\u002Fcontinuous treatment with drugs that affect platelet function (including but not limited to aspirin, clopidogrel, ticagrelor, NSAIDs, etc.) or anticoagulant therapy is required.\n* Allergic constitution or history of severe allergies, or known allergies to the components of the investigational drug excipients.\n* History of important organ transplantation or hematopoietic stem cell\u002Fbone marrow transplantation.\n* History of immunodeficiency, including HIV positivity or other congenital immunodeficiency diseases.\n* Individuals with epilepsy who require treatment.\n* There are clear neurological or mental disorders, or serious psychological or mental abnormalities.\n* Alcoholic or drug abusers.\n* According to the researcher's perspective, other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study or interfere with the interpretation of the research results.\n* It is estimated that the patient's compliance in participating in this clinical study is insufficient.",{"count":159,"type":22},320,[54],"This study is an extension of the TQB3473-III-01 study, aimed at evaluating the safety and efficacy of TQB3473 tablets in adult patients with persistent or chronic ITP who have received at least one ITP standard treatment that is ineffective or has recurred after treatment. This is a single arm, open label, multi cohort, multi center Phase II clinical study.",[28],"2025-07-16",{"date":165,"type":35},"2025-07-24",{"date":167,"type":22},"2025-08",{"date":169,"type":22},"2028-03",{"name":171,"class":42},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",51,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},"100585327","phase-3-a-study-of-tqb3473-tablets-compared-to-placebo-in-the-treatment-of-adult-primary-immune-thrombocytopenia-100585327","NCT06900920","A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n* Subjects voluntarily join this study, sign the informed consent form (ICF), and demonstrate good compliance;\n* Male or female subjects aged 18 to 75 years (calculated based on the date of signing the informed consent form);\n* Eastern Cooperative Oncology Group (ECOG) score of 0-1;\n* Diagnosis of primary ITP prior to randomization, with a duration of ≥12 months;\n* An average of at least three independent platelet counts (spaced more than 3 days apart) within the 3 months prior to randomization \\\u003C30×10\\^9\u002FL, with no count \\>35×10\\^9\u002FL; and no severe bleeding within 4 weeks prior to screening;\n* Previous treatment with glucocorticoids and at least one standard ITP therapy that was ineffective or resulted in relapse.\n* Female subjects of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of study treatment, with a negative serum or urine pregnancy test within 7 days prior to study enrollment; male subjects must agree to use effective contraception during the study and for 6 months after the end of study treatment, as detailed in Section 5.5.\n\nExclusion Criteria:\n\n* Evidence of secondary causes of ITP (e.g., untreated Helicobacter pylori infection, leukemia, lymphoma, history of autoimmune diseases such as systemic lupus erythematosus, Hashimoto's thyroiditis, etc.) or drug-induced causes (e.g., anticonvulsants, antibiotics, heparin, etc.), or immune-mediated cytopenia involving two or more cell lines such as Evans syndrome or immune-related cytopenia;\n* Subjects with a history or current diagnosis of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other malignant hematologic diseases;\n* History of or concurrent other malignancies within the past 3 years. Exceptions include: other malignancies treated with a single surgical procedure and achieving continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\];\n* Conditions affecting venous blood sampling or multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);\n* Adverse reactions from previous treatments have not resolved to ≤CTCAE grade 1, except for non-clinically significant and asymptomatic laboratory abnormalities judged by the investigator to pose no safety risks;\n* Previous bone marrow\u002Fhematopoietic stem cell transplantation or major solid organ transplantation;\n* Vaccination within 8 weeks prior to randomization or planned vaccination during the study period;\n* Major surgical treatment or significant traumatic injury within 4 weeks prior to randomization, or anticipated need for major elective surgery during the study treatment period (major surgery is defined as level 3 or higher according to the National Surgical Classification Catalog 2022);\n* History of intracranial hemorrhage or other severe bleeding in vital organs (≥CTCAE grade 3), or symptomatic gastrointestinal bleeding (e.g., hematemesis, melena, etc., excluding asymptomatic \"occult blood test positive\" and hemorrhoids) within 6 months prior to screening;\n* Arterial\u002Fvenous thrombotic events within 12 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism;\n* ITP-related symptoms and treatments:\n\n  1. Receipt of immunoglobulins or platelet transfusions within 2 weeks prior to randomization;\n  2. Receipt of treatments aimed at increasing platelet counts (including but not limited to glucocorticoids, Thyroid peroxidase (TPO), Thrombopoietin receptor agonists (TPO-RAs), cyclosporine, herbal medicines, etc.) within 4 weeks prior to randomization, except for those meeting inclusion criterion (8);\n  3. Use of rituximab or other anti-cluster of differentiation 20 (CD20) drugs within 14 weeks prior to randomization;\n  4. Splenectomy within 12 weeks prior to randomization.\n* Need for long-term\u002Fcontinuous use of medications affecting platelet function \\[including but not limited to aspirin, clopidogrel, ticagrelor, non-steroidal anti-inflammatory drugs (NSAIDs), etc.\\] or anticoagulant therapy;\n* Known allergy to the active ingredient or excipients of the investigational drug;\n* Previous treatment with Syk inhibitors;\n* Participation in another clinical trial and use of investigational drugs within 4 weeks prior to randomization;\n* Any condition judged by the investigator to pose a significant risk to the subject's safety or to affect the subject's ability to complete the study.","75 Years",{"count":182,"type":22},199,[25],"This is a randomized, double-blind, placebo-controlled Phase III clinical study designed to demonstrate that TQB3473 tablets significantly improve the sustained response rate compared to placebo in adult patients with chronic ITP who have previously received standard corticosteroid therapy and have failed or relapsed after at least one standard ITP treatment.\n\nThe study consists of a treatment period and a safety follow-up period.",[28],"2025-05-18",{"date":188,"type":35},"2025-05-20",{"date":190,"type":35},"2025-04-30",{"date":192,"type":22},"2027-12",{"name":171,"class":42},53,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":150},"100556892","phase-1-role-of-eltrombopag-as-first-line-therapy-in-primary-immune-thrombocytopenia-100556892","NCT06531018","Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.","Efficacy of Eltrombopag & Prednisolone Versus Prednisolone Monotherapy in Newly Diagnosed Immune Thrombocytopenia- A Randomized Control Trial","EIT","Inclusion Criteria:\n\n1. Patients with newly diagnosed ITP\n2. Platelet Count ≤ 30x109\u002FL\n3. Age between 18 to 70 years.\n\nExclusion Criteria:\n\n1. Persistent or chronic ITP\n2. Pregnant women\n3. Secondary ITP- ITP due to SLE, Anti-phospholipid syndrome, Evans syndrome, HCV or H Pylori associated ITP.\n4. History of vaccination, recent viral infection, fever\n5. Evan's Syndrome\n6. Known case of chronic renal failure or liver diseases\n7. Grade 3 or 4 bleeding at presentation.",{"count":204,"type":22},100,[206,54],"PHASE1","This will be a double-blind, placebo-control, randomized clinical trial conducted in the Department of Hematology, DMCH for one year. This study will help to establish the role of eltrombopag as a first-line therapy in newly diagnosed ITP. Newly diagnosed ITP patients will be selected after meeting inclusion and exclusion criteria, they will be thoroughly informed about the study, used drugs, randomization, risks, benefits, and follow-up. If they agree to participate, their consent will be taken and they will be enrolled in the study. A detailed history and clinical exam will be done. Primary investigation will be - CBC PBF, RBS, ANA, TSH, Anti H. pyloriIgG, Anti-HCV, APTT, and BMS (if indicated). The main outcome variable will be platelet count and number of spontaneous bleeding. Total sample size would be 100 (50 in each group). Enrolled patients would be divided into two groups (1:1) by block randomization. One group will get Eltrombopag\\& Prednisolone and other group will get Eltrombopag\\& Placebo. Researchers or any one related to the study in DMCH, patients \\& their attendants, no one will know which patient will get placebo or eltrombopag. Only a respectable third party will know the information. A patient would be followed up on 1st, 2nd and 4th week of starting therapy. Patients would be evaluated in every follow up by history, physical examination and investigation. History of any spontaneous bleeding event, any discomfort or new symptoms science last follow up will be noted. General examination will be performed in every follow-up. CBC, RBS, ALT, AST, creatinine will be done in every follow-up. Data will be collected on a pre-designed case record form and will be collected through face-to-face interviews, physical examination, and laboratory reports. After data collection data will be edited, cleaned, and prepared for analysis at the end of the study. The statistical analysis will be conducted using SPSS version 25 statistical software. The results of the study will be published in national and international journals.",[28],[210,211,212],"Primary ITP","Eltrombopag","First-line Therapy","2025-02-15",{"date":215,"type":35},"2025-02-18",{"date":217,"type":35},"2025-02-07",{"date":219,"type":22},"2025-12-31",{"name":221,"class":42},"Renata PLC",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":150},"100568876","phase-2-study-on-glucocorticoid-combined-with-gamma-globulin-and-ropristine-n01-in-treatment-of-initial-severe-itp-100568876","NCT06686927","Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP","Inclusion Criteria:\n\n1. Participants must sign a written informed consent prior to enrollment;\n2. Ages 18-75;\n3. Platelet count \\\u003C10×10\\^9\u002FL with active bleeding or bleeding score ≥5;\n4. No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;\n5. No prior splenectomy or at least one first-line ITP treatment or emergency treatment;\n6. No prior romiplostim treatment;\n7. ECOG PS score: 0-2;\n8. Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded;\n9. Voluntary participation in this study and good compliance.\n\nExclusion Criteria:\n\n1. Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;\n2. Individuals with a history of thrombosis;\n3. Pregnant or lactating individuals;\n4. Individuals with severe cardiopulmonary insufficiency;\n5. Individuals with severe or uncontrollable infections;\n6. Individuals with viral infections;\n7. Individuals who cannot comply due to psychological reasons;\n8. Individuals who are deemed unsuitable for participation in the study by the investigator.",{"count":229,"type":22},36,[54],"The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is:\n\nTO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month.\n\nParticipants will:\n\nRomiplostim N01, starting dose of 1 µg\u002Fkg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.\n\nIVIG, 400mg\u002Fkg\u002Fd, intravenous administration, continuous administration for 3-5 days.\n\nPrednisone, 0.8mg\u002Fkg\u002Fd, taken orally or intravenously, for up to one month.",[28],[234,235],"severe ITP","Romiplostim","2025-01-19",{"date":238,"type":35},"2025-01-22",{"date":240,"type":35},"2024-11-20",{"date":242,"type":22},"2025-12-20",{"name":244,"class":149},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":150},"100566719","phase-2-a-study-of-romiplostim-n01-as-the-first-line-treatment-for-newly-diagnosed-adult-patients-with-itp-100566719","NCT06658834","A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP","A Multicenter Interventional Study of Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Patients With ITP","Inclusion Criteria:\n\n1. Sign the written informed consent form before enrollment;\n2. Age ranging from 18 to 75 years old;\n3. Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;\n4. Have not received splenectomy or at least one first-line ITP treatment or emergency treatment in the past;\n5. Have not received romiplostim treatment;\n6. ECOG PS score: 0 - 2;\n7. Platelet value \\\u003C 30×10\\^9\u002FL;\n8. The expected survival period at the screening is ≥ 12 weeks;\n9. For subjects of reproductive age, agree to take reliable contraceptive measures throughout the study period (including male or female condoms, contraceptive foams, contraceptive gels, contraceptive membranes, contraceptive ointments, contraceptive suppositories, abstinence, and intrauterine device placement, etc.); Female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or menopause for more than 1 year, and male subjects who have undergone bilateral vasectomy or ligation are excluded;\n10. Voluntarily join this study, sign the informed consent form, and have good compliance.\n\nExclusion Criteria:\n\n1. Suffering from other hematopoietic system diseases except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc.;\n2. Having undergone splenectomy before the first administration;\n3. Having received ITP drug treatment (including emergency treatment) before the first administration;\n4. Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4 weeks before the first administration;\n5. Having received hematopoietic growth factor preparations (such as granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11, etc.) within 4 weeks before the first administration;\n6. Having received antibody drugs (such as rituximab, etc.) within 14 weeks before the first administration;\n7. Having received any Chinese herbal medicine or nutritional supplement (except vitamin supplements and mineral supplements) for the purpose of increasing platelets within 1 week before the first administration;\n8. Having been diagnosed with arterial thrombosis (such as cerebral thrombosis, transient ischemic attack or myocardial infarction), or having a history or complication of venous thrombosis (such as deep vein thrombosis, pulmonary embolism), or using anticoagulants or antiplatelet drugs at the beginning of screening;\n9. Having a history of severe cardiovascular diseases (such as grade III\u002FIV congestive heart failure, arrhythmia or angina pectoris that increases the risk of thromboembolic events, unstable angina pectoris, having undergone coronary artery stent implantation, angioplasty or coronary artery bypass grafting);\n10. Secondary thrombocytopenia caused by autoimmune diseases such as antiphospholipid antibody syndrome, systemic lupus erythematosus, Hashimoto's thyroiditis, Even's syndrome and Sjogren's syndrome;\n11. Positive results for either human immunodeficiency virus antibody or syphilis antibody screening; positive hepatitis C antibody and HCV-RNA exceeding the upper limit of the study center's laboratory test; positive hepatitis B surface antigen and HBV-DNA exceeding the upper limit of the study center's laboratory test;\n12. Having participated in other clinical studies within 3 months before the first administration;\n13. Being pregnant or lactating, or having a pregnancy plan;\n14. Having fertility and being judged by the researcher as not fully adopting contraceptive measures;\n15. Having a history of severe drug allergic reactions or being known to be allergic to glucocorticoids or Nplate® (romiplostim) or the components of QL0911;\n16. Unable to comply for mental reasons;\n17. Judged by the researcher as not suitable to participate in this trial;",{"count":253,"type":22},129,[54],"This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration.\n\nThe subjects will be divided into the experimental group and the control group for treatment.\n\nExperimental group: Dexamethasone (HD-DXM) 40mg\u002Fd × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg\u002Fkg, by subcutaneous injection, once a week, for a maximum of 6 months.\n\nControl group: Dexamethasone (HD-DXM) 40mg\u002Fd × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.",[28],[60,235,258],"Continuous Remission","2024-10-23",{"date":261,"type":35},"2024-10-26",{"date":263,"type":35},"2024-06-01",{"date":265,"type":22},"2026-08-30",{"name":148,"class":149},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":4},"100551956","observational-study-on-the-outcome-of-patients-with-itp-who-underwent-splenectomy-after-2010-100551956","NCT06466824","Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010","Observational Study on the Outcome of Patients With Primary Immune Thrombocytopenia (ITP) Who Underwent Splenectomy After January 1st, 2010","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* Patients with primary ITP according to international criteria \\[2\\], who underwent to splenectomy from 01\u002F01\u002F2010 to 12\u002F31\u002F2022.\n* Obtaining Informed Consent.\n\nExclusion Criteria:\n\n* none",{"count":275,"type":22},157,"Retrospective data collection on ITP patients who underwent splenectomy from 01\u002F01\u002F2010 to 12\u002F31\u002F2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.",[28],[279],"splenectomy","2024-06-14",{"date":282,"type":35},"2024-06-20",{"date":284,"type":22},"2024-09",{"date":286,"type":22},"2025-03",{"name":288,"class":149},"Gruppo Italiano Malattie EMatologiche dell'Adulto"]