[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemophilia-a-with-inhibitors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemophilia-a-with-inhibitors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100653492","a-study-of-elranatamab-for-inhibitor-eradication-in-patients-with-hemophilia-a-100653492",false,"NCT07788469","A Study of Elranatamab for Inhibitor Eradication in Patients With Hemophilia A","A Single-Arm, Open-Label, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Elranatamab for Inhibitor Eradication in Patients With Moderate-to-Severe Hemophilia A With Inhibitors and Poor Prognosis for Inhibitor Eradication","Inclusion Criteria:\n\n* Male or female patients with moderate-to-severe hemophilia A (factor VIII activity \\\u003C2%).\n* Aged 18 to 65 years, inclusive.\n* Positive factor VIII inhibitor detected on at least two consecutive occasions (inhibitor titer \\>0.6 BU\u002FmL).\n* Baseline factor VIII inhibitor titer \\>10 BU\u002FmL at the time of enrollment.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Elranatamab or any of its excipients.\n* Presence of other autoimmune diseases or a need for immunosuppressive therapy for reasons unrelated to this study.\n* History of malignancy within 5 years prior to screening, with the exception of adequately treated carcinoma in situ of the cervix or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma.\n* History of severe recurrent or chronic infections, or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungal agents within 4 weeks before the first dose or during the screening period, or superficial skin infection requiring systemic therapy within 1 week before the first dose.\n* Clinically significant laboratory abnormalities at screening, including:\n\n  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 × the upper limit of normal (ULN).\n  2. Total bilirubin \\>1.5 × ULN (subjects with documented Gilbert syndrome are not excluded based on this criterion);\n  3. Absolute neutrophil count \\\u003C1,500\u002Fmm³;\n  4. Hemoglobin \\\u003C9 g\u002FdL or immunoglobulin G (IgG) \\\u003C500 mg\u002FdL;\n  5. Absolute lymphocyte count \\\u003C500\u002Fmm³;\n  6. Creatinine clearance (CrCl) \\\u003C30 mL\u002Fmin.\n* Positive test for HIV antibody or syphilis antibody.\n* Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (anti-HBc) with detectable HBV DNA by polymerase chain reaction (PCR). Subjects positive for hepatitis C virus (HCV) antibody are excluded.\n* Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study; men whose partners plan to become pregnant during the study.\n* Subjects with psychiatric disorders that impair their ability to provide informed consent or comply with study procedures and follow-up.\n* Subjects with unresolved toxicities from prior therapies before study participation.\n* Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective, single-arm, open-label, exploratory clinical study designed to evaluate the safety and efficacy of Elranatamab for inhibitor eradication in adults with moderate-to-severe hemophilia A with inhibitors. A total of 15-20 patients aged ≥18 years will be enrolled. Elranatamab will be administered with a stepwise dose-escalation regimen of 12 mg on Day 1 and 32 mg on Day 4 during Week 1, followed by the target dose of 38 mg once weekly during Weeks 2-3. Patients will then enter a 4-week follow-up period. If the inhibitor titer decreases by \\\u003C20% from baseline at Week 3, two additional weekly doses of 38 mg may be administered before follow-up. Treatment response will be assessed according to changes in inhibitor titers following treatment.",[26],"Hemophilia A With Inhibitors",[28,29,30],"Hemophilia A","Inhibitors","Elranatamab","NOT_YET_RECRUITING","2026-08-24",{"date":34,"type":35},"2026-08-26","ACTUAL",{"date":37,"type":20},"2026-10",{"date":39,"type":20},"2028-10",{"name":41,"class":42},"Institute of Hematology & Blood Diseases Hospital, China","OTHER"]