[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemophilia-a-with-inhibitor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemophilia-a-with-inhibitor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,74,103,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100412182","phase-4-sevenfact-for-bleeding-events-in-hemophilia-with-inhibitors-100412182",false,"NCT04647227","SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors","Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors","Inclusion Criteria:\n\n1. Have a diagnosis of hemophilia A or B with inhibitors.\n2. Be 12 years of age and older\n3. Be capable of understanding and willing to comply with the conditions of the protocol or have a legal guardian who is capable of understanding and complying with the conditions of the protocol\n4. Have read, understood, and documented written informed consent\u002Fassent\n5. Be able to provide medical evidence through prior medical history of previous inhibitor levels\n6. Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage\n\nExclusion Criteria:\n\n1. Have a disorder of hemostasis in addition to Hemophilia A or B\n2. Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients\n3. Have a known allergy or hypersensitivity to rabbits or rabbit proteins\n4. Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA\n5. Have had implantation of an investigational medical device within the prior 6 months\n6. Have received an investigational drug within 30 days of the baseline visit\n7. Have an elective surgical procedure planned during the duration of their participation in the study\\*\n8. Have any life-threatening disease, or other disease or condition which, in the investigator's judgment, could pose a potential hazard to the patient or interfere with study participation or study outcome (e.g., a history of non responsiveness to bypassing products or thromboembolic disease)\n\n   * Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary. Instead, the participant will receive standard of care treatment as determined by the attending physician. If the participant is not withdrawn from the study, the participant's participation in the study will be paused until the investigator feels it is safe for them to continue.","ALL","12 Years","100 Years",{"count":20,"type":21},55,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.",[27,28],"Hemophilia A With Inhibitor","Hemophilia B With Inhibitor",[30,31,32,33],"Hemophilia A","Hemophilia B","bleeding event","prophylactic treatment","RECRUITING","2026-01-09",{"date":37,"type":38},"2026-01-12","ACTUAL",{"date":40,"type":38},"2021-06-28",{"date":42,"type":21},"2027-03-31",{"name":44,"class":45},"American Thrombosis and Hemostasis Network","NETWORK",21,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100605137","phase-4-understanding-treatment-outcomes-and-immunologic-mechanisms-in-altuviiio-immune-tolerance-induction-100605137","NCT07158606","Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction","Understanding Treatment Outcomes and Immunologic Mechanisms in ALtuviiio Immune Tolerance Induction","UTILITI","Inclusion Criteria:\n\n1\\) severe hemophilia A (congenital) 2) history of high titer inhibitor (≥ 5 BU) 3) peak inhibitor titer (pre-ITI) \\\u003C 1,000 3) age \\\u003C 18 y\u002Fo at the time of study enrollment 4) undergoing initial ITI course 5) current or planned concomitant use of emicizumab\n\nExclusion Criteria:\n\n1. von Willebrand disease or a known second bleeding diathesis besides SHA\n2. prior course of ITI\n3. inhibitor present for \\> 2 years without prior attempts at eradication\n\n3\\) personal history of unprovoked thrombosis 4) known contraindication, intolerance, or allergy to either of the investigational agents of study 5) inability or unwillingness to provide informed consent and\u002For assent 6) inability to speak or read English 7) Any other condition, that in the opinion of the investigator, would negatively impact the safety of the participant","0 Years","17 Years",{"count":58,"type":21},15,[24],"The goal of this clinical trial is to learn how well Altuviiio (efanesoctacog alpha) works for Immune Tolerance Induction (ITI) while using Hemlibra (emicizumab) to prevent bleeds.\n\nParticipants will be given Altuviiio for their ITI therapy and also be treated with Hemlibra as standard of care prophylaxis to prevent bleeding. The research doctor will decide how much and how often the participant will get Hemlibra.\n\nParticipants will need to attend visits for checkups and tests. These visits are divided into 4 periods:\n\n1. A screening period - 1 visit up to 8 weeks before the Treatment Period starts\n2. ITI Treatment Period - 1 Baseline Visit plus Interim visits that occur every 4 weeks for up to 52 weeks. (Some of the interim visits may be done via phone)\n3. Tapering Period - 5 visits at weeks 2, 4, 8, 12 and 16\n4. Ongoing Monitoring Period - 4 visits at weeks 20, 30, 40 and 50",[27],"NOT_YET_RECRUITING","2025-08-28",{"date":65,"type":38},"2025-09-08",{"date":67,"type":21},"2025-10-01",{"date":69,"type":21},"2032-08-31",{"name":71,"class":72},"Versiti Blood Health","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":55,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":73},"100582566","phase-4-assessing-different-fviii-doses-and-frequencies-in-immune-tolerance-induction-iti-with-advate-among-hemophilia-a-boys-with-inhibitor-initiate-study-100582566","NCT06864975","Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)","Assessing Different FVIII Dose and Frequency in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study): a Multicenter Open-label Non-randomized Clinical Trial","Inclusion Criteria:\n\n* Severe hemophilia A (FⅧ:C \\\u003C2%);\n* Positive for FVIII inhibitors;\n* No allergic reactions to FVIII concentrates.\n\nExclusion Criteria:\n\n* Presence of other coagulation-related diseases,\n* Hematological disorders,\n* autoimmune diseases\n* malignancies","MALE","18 Years",{"count":84,"type":21},110,[24],"Hemophilia A is a blood coagulation disorder caused by deficient or dysfunctional clotting factor VIII (FVIII) leading to incomplete haemostasis. Patients with severe Hemophilia A are predisposed to recurrent bleeding episodes (BEs) in joints and soft tissues that culminate in debiltating arthropathy and long-term morbidity. Prophylaxis with plasma-derived or recombinant FVIII concentrates effectively restores FVIII levels in patients with Hemophilia A, and significantly reduces the risk of bleeding. A critical concern for patients receiving FVIII replacement therapy is the development of neutralising antibodies (inhibitors) against the treatment. Inhibitors develop in up to 40% of patients with severe Hemophilia A when first exposed to FVIII treatment, typically within the first 20-30 exposure days (EDs) although a residual risk remains until after 75 EDs. Inhibitors preclude the use of FVIII replacement therapy for prevention and treatment of bleeding.\n\nEradication of inhibitors therefore remains an important objective for Hemophilia A patients with inhibitors. Immune tolerance induction (ITI) therapy is the only clinically proven strategy for inhibitor eradication, and at least one attempt should be offered to patients with inhibitors. However, while ITI is well-studied and has a 60- 80% success rate, treatment regimens can be expensive and burdensome to patients.\n\nThere are limited data on the use of different dose regimen of FVIII ITI in China. The INITIATE Study was designed to observe treatment strategies in patients with hemophilia A with inhibitors, with a focus on evaluating the safety and effectiveness of different dose regimens of ITI. The INITIATE Study includes multiple groups to explore factors that may affect ITI outcomes, and to explore the effects of different treatment methods on patient ITI biomarkers (genomics, transcriptomics, proteins (antibodies).",[88],"Hemophilia a with Inhibitor",[90,91,92,93],"immune tolerance induction","ADVATE","FVIII inhibitor","hemophilia A","2025-03-04",{"date":96,"type":38},"2025-03-07",{"date":98,"type":21},"2025-03-01",{"date":100,"type":21},"2028-06-21",{"name":102,"class":72},"Runhui WU",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":73},"100507552","phase-4-iti-using-sct800-alone-or-combining-daratumumab-in-hemophilia-a-adolescents-and-adults-with-high-titer-inhibitor-100507552","NCT05888870","ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor","The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial","Inclusion Criteria\n\n1. Moderate or severe hemophilia A;\n2. Aged 14-66 years old;\n3. Inhibitor positive at 2 consecutive visits;\n4. Inhibitor titer \\> 10 BU at the screening visit.\n\nExclusion Criteria:\n\n1. The patient has contraindications to drug ingredients or hamster protein allergy;\n2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);\n3. Failed systemic ITI treatment in history;\n4. Poor patients compliance;\n5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.","14 Years","65 Years",{"count":113,"type":21},50,[24],"To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.",[27],"2025-02-20",{"date":119,"type":38},"2025-02-24",{"date":121,"type":38},"2023-11-22",{"date":123,"type":21},"2026-12-01",{"name":125,"class":72},"Institute of Hematology & Blood Diseases Hospital, China",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":81,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":145,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100540729","phase-4-pharmacokinetic-guided-dosing-of-emicizumab-100540729","NCT06320626","Pharmacokinetic-guided Dosing of Emicizumab","Pharmacokinetic-guided Dosing of Emicizumab in Congenital Haemophilia A Patients - The DosEmi Study","DosEmi","Inclusion Criteria:\n\n* Confirmed diagnosis of congenital haemophilia A, with a baseline endogenous FVIII of \\\u003C6 IU\u002Fml\n* Aged \\> 1 year at inclusion (inclusion of children 1-16 years after favourable interim-analysis see protocol)\n* Receiving conventional dosing of emicizumab (6 mg\u002Fkg\u002F4 weeks with varying intervals) for a duration of at least 12 months prior to inclusion;\n* Having good bleeding control, defined as:\n\ni No spontaneous joint\u002Fmuscle bleeds in the previous 6 months AND ii A maximum of two treated (traumatic) bleeds in the previous 6 months.\n\n* Willing and able to provide written informed consent, either by the subject or its parents\u002Flegal guardian\n* Willing to provide bleeding assessment information\n* Willing to adhere to the medication regimen\n\nExclusion Criteria:\n\n* Acquired haemophilia A","1 Year",{"count":136,"type":21},95,[24],"The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients.",[27,140,141,142,143,144],"Hemophilia A Without Inhibitor","Hemophilia A, Severe","Adolescent","Child","Adult",[146,30,147,148,149],"Emicizumab","Monoclonal antibodies","PK-guided dosing","Hemorrhage","2024-03-12",{"date":152,"type":38},"2024-03-20",{"date":154,"type":38},"2022-09-08",{"date":156,"type":21},"2026-08",{"name":158,"class":72},"Kathelijn Fischer",8]