[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657489":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":11,"studyPopulation":11,"armGroups":59,"interventions":65,"overallOfficials":75,"centralContacts":79,"locations":11,"responsibleParty":87,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":11,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":116,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":11},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period",null,"From Month 2 until the clinical cutoff date (at least 7 months of study treatment)",[14,16,18,20,22,24,26,28,30,33,35,38,40,42,44,46,49,51],{"measure":15,"description":11,"timeFrame":12},"ABR for All Bleeds Over the Main Study Treatment Period",{"measure":17,"description":11,"timeFrame":12},"ABR for Treated Spontaneous Bleeds Over the Main Study Treatment Period",{"measure":19,"description":11,"timeFrame":12},"ABR for Treated Joint Bleeds Over the Main Study Treatment Period",{"measure":21,"description":11,"timeFrame":12},"ABR for Treated Target Joint Bleeds Over the Main Study Treatment Period",{"measure":23,"description":11,"timeFrame":12},"Percentage of Participants with Zero Treated Bleeds Over the Main Study Treatment Period",{"measure":25,"description":11,"timeFrame":12},"Number of Injections and Dose per Bleed of Factor VIII or Bypassing Agent Administered to Treat a Bleed Over the Main Study Treatment Period",{"measure":27,"description":11,"timeFrame":12},"Annualized Injection Rate of FVIII or Bypassing Agent Over the Main Study Treatment Period",{"measure":29,"description":11,"timeFrame":12},"Annualized Consumption Rate of FVIII or Bypassing Agent Over the Main Study Treatment Period",{"measure":31,"description":11,"timeFrame":32},"Change from Baseline in the Treatment Burden Domain Score on the Comprehensive Assessment Tool of Challenges in Hemophilia (CATCH) 2.0 Caregiver Questionnaire at Month 8","Baseline and Month 8",{"measure":34,"description":11,"timeFrame":32},"Change from Baseline in the Preoccupation Domain Score on the CATCH 2.0 Caregiver Questionnaire at Month 8",{"measure":36,"description":11,"timeFrame":37},"Incidence and Severity of Adverse Events, With Severity Determined According To National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 Grading Scale","From Baseline until Study Completion (approximately 4 years)",{"measure":39,"description":11,"timeFrame":37},"Incidence and Severity of Thromboembolic Events and Thrombotic Microangiopathy",{"measure":41,"description":11,"timeFrame":37},"Incidence and Severity of Injection-Site Reactions",{"measure":43,"description":11,"timeFrame":37},"Incidence of Adverse Events Leading to Study Drug Discontinuation",{"measure":45,"description":11,"timeFrame":37},"Incidence of Severe Hypersensitivity, Anaphylaxis, or Anaphylactoid Reactions",{"measure":47,"description":11,"timeFrame":48},"Plasma Concentrations of NXT007","At prespecified timepoints from Baseline until Study Completion (approximately 4 years)",{"measure":50,"description":11,"timeFrame":48},"Percentage of Participants With Anti-Drug Antibodies (ADAs) Against NXT007 at Baseline and During the Study",{"measure":52,"description":11,"timeFrame":48},"Percentage of Participants With Neutralizing ADAs Against NXT007",{"allocation":54,"interventionModel":55,"interventionModelDescription":11,"primaryPurpose":56,"observationalModel":11,"timePerspective":11,"maskingInfo":57},"NA","SINGLE_GROUP","TREATMENT",{"masking":58,"maskingDescription":11,"whoMasked":11},"NONE",[60],{"label":61,"type":62,"description":11,"interventionNames":63},"NXT007 Prophylaxis","EXPERIMENTAL",[64],"Drug: NXT007",[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"DRUG","NXT007","NXT007 will be administered subcutaneously (SC) according to the schedule in the protocol.",[61],[72,73,74],"Zemocimig","RO7589655","RG6512",[76],{"name":77,"affiliation":5,"role":78},"Clinical Trials","STUDY_DIRECTOR",[80,85],{"name":81,"role":82,"phone":83,"phoneExt":11,"email":84},"Reference Study ID Number: BO45888 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":86,"role":82,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":88,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[90],{"name":91,"class":6},"Chugai Pharmaceutical","100657489","phase-3-clinical-trial-of-nxt007-for-the-prophylactic-treatment-of-hemophilia-a-in-infants-and-children-100657489",false,"NCT07838194","Clinical Trial of NXT007 for the Prophylactic Treatment of Hemophilia A in Infants and Children","A Multicenter, Open-Label, Single-Arm, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of NXT007 Prophylaxis in Pediatric Patients With Hemophilia A","ZEBRHA 3","Inclusion Criteria:\n\n* Age \\\u003C12 years at the time of signing Informed Consent Form; or age ≥12 and \\\u003C18 years with body weight \\\u003C40 kg\n* Diagnosis of severe (Factor VIII coagulation protein activity \\[FVIII:C\\] \\\u003C1 International Unit per decilitre \\[IU\u002FdL\\]) or moderate (FVIII:C between ≥1 IU\u002FdL and ≤5 IU\u002FdL) congenital hemophilia A (HA) with or without inhibitors against factor VIII (FVIII)\n* For potential participants with moderate HA without inhibitors, fulfillment of at least one of the following criteria: Current prophylaxis with long-term prophylaxis intention due to a severe bleed phenotype; For those not treated with prophylaxis: at least one traumatic joint or critical muscle bleed in the last 6 months or ≥2 spontaneous bleeds\u002Fyear or 5 bleeds\u002Fyear, including traumatic bleeds; Signs of joint degeneration compatible with hemophilic arthropathy (e.g., subchondral bone changes or the presence of synovitis) as assessed by any imaging assessment (e.g., ultrasound, MRI, radiograph); Bleeding at a critical site (e.g., intracranial).\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* 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 if appropriate\n* For potential participants taking on-demand treatments prior to study entry: agreement to move to a prophylaxis treatment with NXT007\n* Adequate renal, hepatic, and hematologic function, as defined in the protocol\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* History or conditions, other than HA, which may indicate hypo- or hypercoagulopathy risk\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)\n* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study","ALL","0 Years","17 Years",{"count":104,"type":105},50,"ESTIMATED","INTERVENTIONAL",[108],"PHASE3","The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis in pediatric patients aged 0 to 11 years with severe or moderate congenital hemophilia A without factor VIII inhibitors or congenital hemophilia A of any severity (severe, moderate, and mild) with inhibitors (emicizumab-naïve and treated). Patients with hemophilia A aged ≥12 to \\\u003C18 years old with a body weight of \\\u003C40 kilograms (kg) are also able to participate.",[111],"Hemophilia A",[113,114,115],"Factor VIII","Inhibitors","Bypassing agents","NOT_YET_RECRUITING","2026-09-17",{"date":119,"type":120},"2026-09-24","ACTUAL",{"date":122,"type":105},"2026-11-30",{"date":124,"type":105},"2031-09-30",{"name":5,"class":6}]