[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653492":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":24,"interventions":31,"overallOfficials":37,"centralContacts":42,"locations":50,"responsibleParty":61,"collaborators":17,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":17,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":17,"enrollmentInfo":72,"targetDuration":17,"studyType":75,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":83,"whyStopped":17,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events (AES)","AES was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.","1 year",[14],{"measure":15,"description":16,"timeFrame":12},"The proportion of patients who achieve successful inhibitor eradication","the number of patients with successful inhibitor eradication divided by the total number of patients in the study, expressed as a percentage.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE",[25],{"label":26,"type":27,"description":28,"interventionNames":29},"hemophilia A with inhibitors receiving Elranatamab at a stepwise dose-escalation regimen","EXPERIMENTAL","Elranatamab will be administered with a stepwise dose-escalation regimen",[30],"Drug: Elranatamab",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":17},"DRUG","Elranatamab","Patients receive Elranatamab at 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. If the inhibitor titer decreases by \\>20% from baseline at Week 3, no further treatment will be given, and patients will proceed directly to follow-up.",[26],[38],{"name":39,"affiliation":40,"role":41},"Lei Zhang","Chinese Academy of Medical Science and Blood Disease Hospital","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":17,"email":47},"Wei Liu","CONTACT","+8613820261971","liuwei1@ihcams.ac.cn",{"name":39,"role":45,"phone":17,"phoneExt":17,"email":49},"zhanglei1@ihcams.ac.cn",[51],{"facility":40,"status":17,"city":52,"state":17,"zip":17,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":17},"Tianjin","China","CN",{"type":56,"coordinates":57},"Point",[58,59],117.17667,39.14222,{"lat":59,"lon":58},{"type":62,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","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":73,"type":74},20,"ESTIMATED","INTERVENTIONAL",[19],"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.",[79],"Hemophilia A With Inhibitors",[81,82,34],"Hemophilia A","Inhibitors","NOT_YET_RECRUITING","2026-08-24",{"date":86,"type":87},"2026-08-26","ACTUAL",{"date":89,"type":74},"2026-10",{"date":91,"type":74},"2028-10",{"name":5,"class":6},1]