[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619640":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":11,"armGroups":42,"interventions":51,"overallOfficials":11,"centralContacts":59,"locations":65,"responsibleParty":84,"collaborators":11,"id":86,"slug":11,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":11,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":11,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Hemab ApS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of treatment-emergent adverse events (TEAEs)",null,"Day 1 through Day 57",[14,16,19,21,23,25,27,29,31,33],{"measure":15,"description":11,"timeFrame":12},"Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig",{"measure":17,"description":11,"timeFrame":18},"Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax)","Baseline through Day 57",{"measure":20,"description":11,"timeFrame":12},"Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)",{"measure":22,"description":11,"timeFrame":12},"Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf)",{"measure":24,"description":11,"timeFrame":12},"Pharmacokinetic Parameter: Terminal elimination phase half-life (T1\u002F2)",{"measure":26,"description":11,"timeFrame":12},"Pharmacodynamic Parameter: Total Factor VII",{"measure":28,"description":11,"timeFrame":12},"Pharmacodynamic Parameter: Factor VII Activity",{"measure":30,"description":11,"timeFrame":12},"Pharmacodynamic Parameter: Prothrombin time (PT) Measurement",{"measure":32,"description":11,"timeFrame":12},"Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement",{"measure":34,"description":11,"timeFrame":12},"Anti-drug antibody levels",{"allocation":36,"interventionModel":37,"interventionModelDescription":11,"primaryPurpose":38,"observationalModel":11,"timePerspective":11,"maskingInfo":39},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":40,"maskingDescription":11,"whoMasked":11},"NONE","The objective is to administer a single dose of sutacimig and to evaluate safety, pharmacokinetics, and pharmacodynamics. Two cohorts may be evaluated. Cohort A is defined by participants with a FVII(a) level of \\\u003C 10%. Cohort B is defined by participants with a FVII(a) level of ≥10%.",[43,48],{"label":44,"type":45,"description":11,"interventionNames":46},"Participants with a FVII(a) level of \u003C 10%","EXPERIMENTAL",[47],"Drug: Sutacimig",{"label":49,"type":45,"description":11,"interventionNames":50},"Participants with a FVII(a) level of ≥10%",[47],[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"DRUG","Sutacimig","Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.",[44],{"type":53,"name":54,"description":55,"armGroupLabels":58,"otherNames":11},[49],[60],{"name":61,"role":62,"phone":63,"phoneExt":11,"email":64},"Hemab Aps","CONTACT","+44 (0) 808 304 6409","clinicaltrials@hemab.com",[66],{"facility":67,"status":68,"city":69,"state":11,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Royal London Hospital","RECRUITING","London","E1 2ES","United Kingdom","UK",{"type":74,"coordinates":75},"Point",[76,77],-0.12574,51.50853,{"lat":77,"lon":76},[80],{"name":81,"role":62,"phone":82,"phoneExt":11,"email":83},"Suthesh Sivapalarantnam","+44 (0) 020 3594 3327","s.sivapalaratnam@nhs.net",{"type":85,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100619640",false,"NCT07347249","A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency","A Clinical Study to Assess the Safety and Efficacy of Sutacimig in Participants With Congenital Factor VII Deficiency","Inclusion Criteria:\n\n1. Age 18 to 60 years, inclusive, at the time of signing informed consent.\n2. Diagnosis of FVIID defined by Factor VII:C activity \\\u003C 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment.\n3. Severe bleeding history characterized by history of a major bleeding event and\u002For receipt of recombinant activated FVII or fresh frozen plasma as treatment for bleeding or a severe clinical bleeding history as defined by the Investigator.\n4. Has the ability to provide informed consent to participate in the trial.\n\nExclusion Criteria:\n\n1. Presence of known inhibitors to FVII or FVIIa\n2. History of clinically significant hypersensitivity associated with monoclonal antibody therapies.\n3. History of venous or arterial thrombosis or thromboembolic disease, with the exception of catheter-associated superficial vein thrombosis.\n4. Known thrombophilia risk by the following criteria: Homozygous Factor V Leiden (FVL), compound heterozygous FVL\u002FProthrombin gene mutation, antithrombin \\\u003C50%, congenital protein C, and protein S deficiency with levels \\\u003C50%.\n5. Clinically significant comorbidity that may interfere with study participation.\n6. Use of concomitant therapy not permitted during the study (i.e., other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment \\[e.g., for oral bleeds\\])\n7. Female participants who are pregnant or breastfeeding.","ALL","18 Years","60 Years",{"count":96,"type":97},18,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","Open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of sutacimig monotherapy in participants with congenital FVII deficiency (FVIID).",[103],"Congenital Factor VII Deficiency",[103,105,106,107],"Factor VII Deficiency","FVIID","Congenital coagulation factor VII (FVII) deficiency","2026-05-28",{"date":110,"type":111},"2026-05-29","ACTUAL",{"date":113,"type":111},"2026-03-11",{"date":115,"type":97},"2026-07",{"name":5,"class":6},1]