[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624974":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":135,"collaborators":137,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":52,"enrollmentInfo":150,"targetDuration":52,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":52,"overallStatus":59,"whyStopped":52,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Main Study Treatment Period: NXT007 Prophylaxis","EXPERIMENTAL","Participants randomized to this arm will receive NXT007 prophylaxis for the main study treatment period.",[13],"Combination Product: NXT007",{"label":15,"type":16,"description":17,"interventionNames":18},"Main Study Treatment Period: Emicizumab Prophylaxis","ACTIVE_COMPARATOR","Participants randomized to this arm will receive emicizumab prophylaxis for the main study treatment period at 3 mg\u002Fkg once weekly (QW) for 4 weeks as loading doses, followed by maintenance dosing of either 1.5 mg\u002Fkg QW, 3 mg\u002Fkg once every 2 weeks (Q2W), or 6 mg\u002Fkg once every 4 weeks (Q4W). Loading doses are not required for participants who were taking emicizumab prior to study start.",[19],"Drug: Emicizumab",{"label":21,"type":10,"description":22,"interventionNames":23},"Open-Label Extension Period: NXT007 Prophylaxis","After the main study treatment period, participants in the NXT007 arm will be able to continue with NXT007 dosing, and participants in the Emicizumab arm will be able to switch to NXT007, in the open-label extension period.",[13],[25,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"COMBINATION_PRODUCT","NXT007","NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.",[9,21],[31,32,33],"Zemocimig","RO7589655","RG6512",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Emicizumab","Emicizumab will be administered subcutaneously (SC) using vial and syringe.",[15],[40,41,42],"Hemlibra","RO5534262","RG6013",[44],{"name":45,"affiliation":5,"role":46},"Clinical Trials","STUDY_DIRECTOR",[48,54],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Reference Study ID Number: BO45887 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. Only)",null,"global-roche-genentech-trials@gene.com",{"name":55,"role":50,"phone":52,"phoneExt":52,"email":52},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[57,71,81,91,98,110,120,130],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":52},"Center for Inherited Blood Disorders","RECRUITING","Orange","California","92868","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-117.85311,33.78779,{"lat":69,"lon":68},{"facility":72,"status":59,"city":73,"state":74,"zip":75,"country":63,"countryCode":64,"cosmosGeoPoint":76,"geoPoint":80,"contacts":52},"Innovative Hematology, Inc.","Indianapolis","Indiana","46260",{"type":66,"coordinates":77},[78,79],-86.15804,39.76838,{"lat":79,"lon":78},{"facility":82,"status":59,"city":83,"state":84,"zip":85,"country":63,"countryCode":64,"cosmosGeoPoint":86,"geoPoint":90,"contacts":52},"Washington Center for Bleeding Disorders","Seattle","Washington","98101-3932",{"type":66,"coordinates":87},[88,89],-122.33207,47.60621,{"lat":89,"lon":88},{"facility":92,"status":59,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":52,"geoPoint":52,"contacts":52},"The Chaim Sheba Medical Center - PPDS","Ramat Gan","Central District","5262100","Israel","IL",{"facility":99,"status":59,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":52},"Nagoya University Hospital","Nagoya","Aiti","466-8560","Japan","JP",{"type":66,"coordinates":106},[107,108],136.90641,35.18147,{"lat":108,"lon":107},{"facility":111,"status":59,"city":112,"state":113,"zip":114,"country":103,"countryCode":104,"cosmosGeoPoint":115,"geoPoint":119,"contacts":52},"Gunma University Hospital","Maebashi","Gunma","371-8511",{"type":66,"coordinates":116},[117,118],139.08333,36.4,{"lat":118,"lon":117},{"facility":121,"status":59,"city":122,"state":123,"zip":124,"country":103,"countryCode":104,"cosmosGeoPoint":125,"geoPoint":129,"contacts":52},"Nara Medical University Hospital","Kashihara-shi","Nara","634-8522",{"type":66,"coordinates":126},[127,128],135.7929,34.50896,{"lat":128,"lon":127},{"facility":131,"status":59,"city":132,"state":133,"zip":134,"country":103,"countryCode":104,"cosmosGeoPoint":52,"geoPoint":52,"contacts":52},"Ogikubo Hospital","Suginami-Ku","Tokyo","167-0035",{"type":136,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[138],{"name":139,"class":6},"Chugai Pharmaceutical","100624974","phase-3-a-clinical-study-to-evaluate-the-effects-of-nxt007-compared-to-emicizumab-prophylaxis-in-people-with-hemophilia-a-100624974",false,"NCT07416604","A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A","A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Emicizumab Prophylaxis in People With Hemophilia A","ZEBRHA 2","Inclusion Criteria:\n\n* Diagnosis of severe (FVIII:C \\\u003C1 International Unit per decilitre \\[IU\u002FdL\\]) or moderate (FVIII:C between ≥1 IU\u002FdL and ≤5 IU\u002FdL) congenital hemophilia A with or without inhibitors against FVIII\n* Diagnosis of mild (FVIII:C between \\>5 IU\u002FdL and \\\u003C40 IU\u002FdL) congenital hemophilia A with chronic FVIII inhibitors, defined as documented FVIII inhibitor ( ≥0.6 BU\u002FmL or ≥1.0 BU\u002FmL only for laboratories with a historical sensitivity cutoff for inhibitor detection of 1.0 BU\u002FmL) and chronic reduction of endogenous baseline FVIII:C to \\\u003C5 IU\u002FdL for ≥12 months\n* Documented historical FVIII inhibitor assay results within the 12 months prior to enrollment\n* Documentation of the details of prophylactic and episodic FVIII treatment, bypassing agent (BPA) treatment, emicizumab prophylaxis treatment, and the number and type of bleeding episodes for at least the last 6 months prior to screening\n* For potential participants taking on-demand treatments prior to study entry: agreement to move to a prophylaxis treatment with either emicizumab or NXT007, according to assigned randomization\n\nExclusion Criteria:\n\n* Sensitivity to any of the study investigations, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study\n* Use of systemic immunomodulators (e.g., interferon or rituximab) at the time of enrollment or planned use during the study, except for antiretroviral therapy to treat HIV\n* Refusal to accept plasma-derived and\u002For blood product transfusion support in an emergency scenario\n* Planned surgery (excluding minor procedures, such as non-molar tooth extraction or incision and drainage) during the study\n* History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing)\n* History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence or clinical history of prior myocardial infarction","ALL","12 Years",{"count":151,"type":152},360,"ESTIMATED","INTERVENTIONAL",[155],"PHASE3","The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity (severe, moderate, and mild) with FVIII inhibitors.",[158],"Hemophilia A","2026-06-04",{"date":161,"type":162},"2026-06-08","ACTUAL",{"date":164,"type":162},"2026-04-27",{"date":166,"type":152},"2032-01-29",{"name":5,"class":6},8]