[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemorrhagic-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemorrhagic-disorders":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,75,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100627863","bleeding-disorder-of-unknown-cause-in-the-netherlands-100627863",false,"NCT07454161","Bleeding Disorder of Unknown Cause in the Netherlands","Bleeding Disorder of Unknown Cause In the Netherlands (BDUC-iN Study)","BDUC-iN","Inclusion Criteria:\n\n* Referred to a (pediatric) hemostasis specialist for evaluation of bleeding tendency.\n* Increased bleeding tendency based on: Abnormal International Society on Thrombosis and Haemostasis Bleeding Assessment Tool (ISTH-BAT) score (≥ 5 in women age 18-30; ≥ 6 in women age 31-51, ≥ 7 in women age 52 or older; ≥4 in men and ≥ 3 in children) OR Clinical gestalt according to the investigating physician\n* Absence of diagnostic test results for a bleeding disorder in standard laboratory hemostasis tests:\n* Complete blood count: Hemoglobin \\> 6.0 mmol\u002FL; thrombocyte count \\> 100 x10\\^9\u002FL\n* Prothrombin (PT) and activated Partial Thromboplastin Time (aPTT): within local reference range, or prolonged without explanatory factor deficiency\n* Fibrinogen activity, von Willebrand Factor (VWF) antigen \\& activity, Factor VIII, IX, XI and XIII: within local reference range or abnormal but not explaining bleeding phenotype\n* Light transmission aggregometry (LTA): Not diagnostic for a platelet function\n* Kidney function: eGFR \\> 45 ml\u002Fmin\n* Liver function: ALAT, bilirubin \\\u003C 3 x upper limit of normal\n\nExclusion Criteria:\n\n* Use of medication interfering with laboratory hemostasis tests which cannot be stopped before blood withdrawal\n* Pregnancy or lactation at moment of inclusion\n* Presence of an established bleeding disorder\n* Presence of an acquired cause or another explanation for the increased bleeding tendency\n* Inability to provide informed consent","ALL","12 Years",{"count":20,"type":21},500,"ESTIMATED","10 Years","OBSERVATIONAL","The purpose of the Bleeding Disorder of Unknown Cause in the Netherlands study (BDUC-iN) is to learn more about unexplained bleeding in individuals with a bleeding disorder of unknown cause (BDUC). The study aims to better understand why these individuals have increased bleeding and how it affects their health and daily life.\n\nThe main questions of this study are:\n\n1. What are the mechanisms underlying the bleeding tendency in BDUC?\n2. How do bleeding symptoms affect patients' daily functioning and overall health-related quality of life?\n3. How is care delivered to individuals with BDUC, and how can this be improved?\n\nParticipants with increased bleeding tendency who remain undiagnosed after standard coagulation testing and are consequently classified as having BDUC will be enrolled across the Hemophilia treatment centers in the Netherlands. Participants will undergo blood sampling for advanced hemostasis testing and genetic analysis. In addition, participants will complete validated questionnaires to assess bleeding symptoms and health-related quality of life. Participants will be followed longitudinally to evaluate how bleeding symptoms affect daily activities, medical procedures, and overall health-related quality of life.",[26,27],"Hemorrhagic Disorders","Bleeding Disorder of Unknown Cause",[29,30,31,32,33,34,35],"Bleeding disorder of unknown cause","Hemostasis","Diagnosis","Management","Pathofysiology","Quality of life","Prospective","RECRUITING","2026-04-23",{"date":39,"type":40},"2026-04-27","ACTUAL",{"date":42,"type":21},"2026-05-01",{"date":44,"type":21},"2039-03-01",{"name":46,"class":47},"Maastricht University Medical Center","OTHER",8,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100570329","comparative-evaluation-of-the-performance-of-different-thromboplastin-reagents-on-prothrombin-time-and-factorial-assays-in-situations-of-isolated-extrinsic-pathway-factor-deficiency-or-liver-damage-100570329","NCT06705829","Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage.","Inclusion criteria :\n\n* Plasma samples from patients addressed to the laboratory of the Strasbourg University Hospital (Strasbourg France) collected and anonymized after completion of the routine testing.\n* Patient with an isolated or combined extrinsic pathway factor deficiency (factor II, V, VII, X).\n\nExclusion criteria :\n\n* Patient treated with an oral anticoagulant treatment.\n* Patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).","18 Years",{"count":57,"type":21},100,"Primary purpose :\n\nCompare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor II, V, VII and X assays in two different populations of patients :\n\n* Patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor II or V or VII or X.\n* Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment).\n\nResults of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors II, V, VII, X assays. This work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory\u002Fcenter.",[26,60,61],"Extrinsic Pathway Factor Deficiency","Hepatocellular Insufficiency With Coagulopathy",[63,64],"Thromboplastin sensitivity","Prothrombin time","2025-08-04",{"date":67,"type":40},"2025-08-08",{"date":69,"type":40},"2024-12-14",{"date":71,"type":21},"2025-12",{"name":73,"class":47},"University Hospital, Strasbourg, France",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":58,"conditions":88,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100590974","phase-4-comparative-evaluation-of-the-performance-of-different-thromboplastin-reagents-on-prothrombin-time-in-situations-of-isolated-extrinsic-pathway-factor-deficiency-or-liver-damage-100590974","NCT06974396","Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage","Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage","RHEOMICS","Inclusion Criteria:\n\n* Plasma samples from patients addressed to the laboratory of the Strasbourg University Hospital (Strasbourg France) collected and anonymized after completion of the routine testing.\n* Patient with an isolated or combined extrinsic pathway factor deficiency (factor II, V, VII, X).\n\nExclusion Criteria:\n\n* Patient treated with an oral anticoagulant treatment.\n* Patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).",{"count":84,"type":21},20,"INTERVENTIONAL",[87],"PHASE4",[26],"NOT_YET_RECRUITING","2025-08-01",{"date":92,"type":40},"2025-08-06",{"date":94,"type":21},"2025-09-01",{"date":96,"type":21},"2026-12-01",{"name":73,"class":47},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":85,"phases":108,"briefSummary":110,"conditions":111,"keywords":125,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":74},"100536932","phase-1-a-study-to-evaluate-the-safety-pkpd-of-oricar-017-in-subjects-with-rrmm---rigel-study-100536932","NCT06271252","A Study to Evaluate the Safety, PK\u002FPD of (OriCAR-017) in Subjects With RR\u002FMM - RIGEL Study","A Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product (OriCAR-017) in Subjects With Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\nCapable of giving signed informed consent\n\nSubjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).\n\nExpected survival period is \\>12 weeks.\n\nDiagnosis of MM according to the IMWG criteria (2016 version).\n\nOne of the following criteria must be met:\n\nIf immunoglobulin (Ig)G type MM, then serum M protein \\>10 g\u002FL; if IgA, IgD, IgE or IgM type MM, then serum M protein \\>5 g\u002FL\n\nUrine M protein level \\>200 mg\u002F24 hour\n\nIf light chain type MM, then serum free light chain (sFLC) \\>100 mg\u002FL and K\u002Fλ FLC ratio is abnormal.\n\nExtramedullary lesions (\\>1 cm for diameter of the short axis).\n\nFor Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.\n\nFor Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)\n\nSubjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.\n\nSubject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.\n\nExclusion Criteria:\n\nPregnant or breastfeeding.\n\nSeropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection\n\nKnown active or prior history of CNS involvement\n\nHistory of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years\n\nPresence of uncontrolled active infection\n\nSubjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.\n\nSubjects who received allogeneic stem cell therapy.\n\nAny condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.\n\nReceived Bendamustine treatment 1 year prior to Screening Visit.","75 Years",{"count":107,"type":21},81,[109],"PHASE1","The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed\u002Frefractory multiple myeloma.\n\nRIGEL Study",[112,113,114,115,116,117,118,119,120,26,121,122,123,124],"Neoplasms, Plasma Cell","Neoplasms by Histologic Type","Neoplasms","Hemostatic Disorders","Vascular Diseases","Cardiovascular Diseases","Paraproteinemias","Blood Protein Disorders","Hematologic Diseases","Lymphoproliferative Disorders","Immunoproliferative Disorders","Immune System Diseases","Multiple Myeloma",[126],"R\u002FR MM, CAR-T","2024-08-01",{"date":129,"type":40},"2024-08-02",{"date":131,"type":40},"2024-04-03",{"date":133,"type":21},"2028-04-12",{"name":135,"class":136},"OriCell Therapeutics Co., Ltd.","INDUSTRY"]