[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07220564":3,"trial-entities:NCT07220564":354,"trial-summary:NCT07220564":359},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":94,"locations":96,"central_contacts":342,"overall_officials":348,"references":352,"see_also_links":353},"NCT07220564","NN7442-8454","A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A","RECRUITING","2027-02-05","2026-08","2026-08-10","2025-10-23","Novo Nordisk A\u002FS","INDUSTRY",false,"This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.",null,[19],"Haemophilia A",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":37},"DRUG","NNC0442-0344 A","NNC0442-0344 A will be administered orally.",[34,35,36],"Cohort 1","Cohort 2","Cohort 3",[38],"Inno8",[40],{"measure":41,"description":42,"timeFrame":43},"Number of treatment emergent adverse events","Measured as count of events.","From time of dosing (Day 1) to end of follow-up (Day 46)",[45,48,51,53,55,58,62,66,69,72],{"measure":46,"description":47,"timeFrame":43},"Change in D-dimer","Measured as absolute and percentage (%).",{"measure":49,"description":50,"timeFrame":43},"Change in prothrombin fragment 1 and 2","Measured as absolute and %.",{"measure":52,"description":50,"timeFrame":43},"Change in fibrinogen",{"measure":54,"description":50,"timeFrame":43},"Change in platelets",{"measure":56,"description":57,"timeFrame":43},"Occurrence of anti-Inno8 antibodies","Measured as count.",{"measure":59,"description":60,"timeFrame":61},"Cmax: the maximum concentration of Inno8 after multiple doses","Measured as nanograms per millilitre (ng\u002FmL).","From Day 10 to Day 11",{"measure":63,"description":64,"timeFrame":65},"Tmax: the time to Cmax after last multiple dose","Measured as hours.","From day 10 to Day 11",{"measure":67,"description":64,"timeFrame":68},"Tmax: the time to Cmax after first dose","From Day 1 to Day 2",{"measure":70,"description":71,"timeFrame":61},"AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses","Measured as nanograms\\*day per millilitre (ng\\*day\u002FmL).",{"measure":73,"description":74,"timeFrame":61},"Maximum thrombin generation (peak height)","Measured as nanomolar (nM).","MALE","18 Years","64 Years",true,{"inclusion":80,"exclusion":85,"raw_text":93},[81,82,83,84],"Male","Age 18-64 years (both inclusive) at the time of signing the informed consent.","Body weight greater than or equal to (≥) 45 kilograms (kgs).","Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.",[86,87,88,89,90,91,92],"Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.","Body mass index ≥30.0 kilogram per square meter (kg\u002Fm\\^2).","Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis.","Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.","Any known coagulation disorders other than haemophilia A.","Ongoing or planned immune tolerance induction therapy.","Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and\u002For nutrients, as judged by the investigator.","Inclusion Criteria:\n\n* Male\n* Age 18-64 years (both inclusive) at the time of signing the informed consent.\n* Body weight greater than or equal to (≥) 45 kilograms (kgs).\n* Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.\n\nExclusion Criteria:\n\n* Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.\n* Body mass index ≥30.0 kilogram per square meter (kg\u002Fm\\^2).\n* Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis.\n* Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.\n* Any known coagulation disorders other than haemophilia A.\n* Ongoing or planned immune tolerance induction therapy.\n* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and\u002For nutrients, as judged by the investigator.",[95],"ADULT",[97,106,114,122,130,137,145,152,161,169,177,184,191,199,206,214,221,228,235,242,249,257,261,269,276,283,290,297,305,312,320,328,335],{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":102,"geoPoint":103},"UC Denver Hemoph & Thrombo Ctr","Aurora","Colorado","80045","United States",{"lat":104,"lon":105},39.72943,-104.83192,{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":102,"geoPoint":111},"Indiana Hemophilia-Thromb Ctr","Indianapolis","Indiana","46260",{"lat":112,"lon":113},39.76838,-86.15804,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":102,"geoPoint":119},"University of Iowa_Iowa City","Iowa City","Iowa","52242",{"lat":120,"lon":121},41.66113,-91.53017,{"facility":123,"status":8,"city":124,"state":125,"zip":126,"country":102,"geoPoint":127},"Penn State MS Hershey Med Ctr","Hershey","Pennsylvania","17033-2360",{"lat":128,"lon":129},40.28592,-76.65025,{"facility":131,"status":8,"city":132,"state":125,"zip":133,"country":102,"geoPoint":134},"St Christopher Hosp for Child","Philadelphia","19134",{"lat":135,"lon":136},39.95238,-75.16362,{"facility":138,"status":8,"city":139,"zip":140,"country":141,"geoPoint":142},"Universitätsklinik für Innere Medizin V","Innsbruck","6020","Austria",{"lat":143,"lon":144},47.26266,11.39454,{"facility":146,"status":8,"city":147,"zip":148,"country":141,"geoPoint":149},"AKH - Klin. Abt. f. Haematologie u. Haemostaseologie","Vienna","1090",{"lat":150,"lon":151},48.20849,16.37208,{"facility":153,"status":154,"city":155,"zip":156,"country":157,"geoPoint":158},"Cliniques universitaires Saint-Luc","NOT_YET_RECRUITING","Brussels","1200","Belgium",{"lat":159,"lon":160},50.85045,4.34878,{"facility":162,"status":8,"city":163,"zip":164,"country":165,"geoPoint":166},"HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique","Bron","69500","France",{"lat":167,"lon":168},45.73865,4.91303,{"facility":170,"status":8,"city":171,"zip":172,"country":173,"geoPoint":174},"Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain","Berlin","10249","Germany",{"lat":175,"lon":176},52.52437,13.41053,{"facility":178,"status":154,"city":179,"zip":180,"country":173,"geoPoint":181},"Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie","Bonn","53127",{"lat":182,"lon":183},50.73438,7.09549,{"facility":185,"status":8,"city":186,"zip":187,"country":173,"geoPoint":188},"Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie","Hanover","30625",{"lat":189,"lon":190},52.37052,9.73322,{"facility":192,"status":8,"city":193,"zip":194,"country":195,"geoPoint":196},"AOU Careggi Firenze","Florence","50134","Italy",{"lat":197,"lon":198},43.77925,11.24626,{"facility":200,"status":8,"city":201,"zip":202,"country":195,"geoPoint":203},"Azienda Ospedaliera Universitaria Federico II di Napoli","Naples","80131",{"lat":204,"lon":205},40.85216,14.26811,{"facility":207,"status":8,"city":208,"zip":209,"country":210,"geoPoint":211},"Uniwersytecki Szpital Kliniczny w Bialymstoku","Bialystok","15-276","Poland",{"lat":212,"lon":213},53.13333,23.16433,{"facility":215,"status":8,"city":216,"zip":217,"country":210,"geoPoint":218},"Uniwersyteckie Centrum Kliniczne","Gdansk","80-214",{"lat":219,"lon":220},54.35227,18.64912,{"facility":222,"status":154,"city":223,"zip":224,"country":210,"geoPoint":225},"Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach","Katowice","40-032",{"lat":226,"lon":227},50.2597,19.02173,{"facility":229,"status":154,"city":230,"zip":231,"country":210,"geoPoint":232},"Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku","Lublin","20-081",{"lat":233,"lon":234},51.25058,22.57009,{"facility":236,"status":154,"city":237,"zip":238,"country":210,"geoPoint":239},"Uniwersytecki Szpital Kliniczny W Poznaniu","Poznan","60-569",{"lat":240,"lon":241},52.40692,16.92993,{"facility":243,"status":8,"city":244,"zip":245,"country":210,"geoPoint":246},"Instytut Hematologii i Transfuzjologii","Warsaw","02-776",{"lat":247,"lon":248},52.22977,21.01178,{"facility":250,"status":154,"city":251,"zip":252,"country":253,"geoPoint":254},"ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia","Porto","4050-342","Portugal",{"lat":255,"lon":256},41.1485,-8.61097,{"facility":258,"status":8,"city":251,"zip":259,"country":253,"geoPoint":260},"ULS São João, E.P.E._H.São João_Imunohemoterapia","4200-319",{"lat":255,"lon":256},{"facility":262,"status":8,"city":263,"zip":264,"country":265,"geoPoint":266},"Hospital Vall d'Hebron","Barcelona","08035","Spain",{"lat":267,"lon":268},41.38879,2.15899,{"facility":270,"status":8,"city":271,"zip":272,"country":265,"geoPoint":273},"Hospital Universitario La Paz","Madrid","28046",{"lat":274,"lon":275},40.4165,-3.70256,{"facility":277,"status":8,"city":278,"zip":279,"country":265,"geoPoint":280},"Hospital Regional Universitario de Málaga","Málaga","29010",{"lat":281,"lon":282},36.72016,-4.42034,{"facility":284,"status":8,"city":285,"zip":286,"country":265,"geoPoint":287},"Hospital Clinico Universitario de Salamanca","Salamanca","37007",{"lat":288,"lon":289},40.96882,-5.66388,{"facility":291,"status":8,"city":292,"zip":293,"country":265,"geoPoint":294},"Hospital La Fe_Hemostasia y Trombosis","Valencia","46026",{"lat":295,"lon":296},39.47391,-0.37966,{"facility":298,"status":8,"city":299,"zip":300,"country":301,"geoPoint":302},"Skåne US - Koagulationsmottagning","Malmö","214 28","Sweden",{"lat":303,"lon":304},55.60587,13.00073,{"facility":306,"status":8,"city":307,"zip":308,"country":301,"geoPoint":309},"KS Solna - Koagulationsmottagningen","Solna","171 64",{"lat":310,"lon":311},59.36004,18.00086,{"facility":313,"status":154,"city":314,"zip":315,"country":316,"geoPoint":317},"Zentrum für Labormedizin","Sankt Gallen","9008","Switzerland",{"lat":318,"lon":319},47.42391,9.37477,{"facility":321,"status":8,"city":322,"zip":323,"country":324,"geoPoint":325},"Queen Elizabeth Hospital, Birmingham - Haemophilia","Birmingham","B15 2TH","United Kingdom",{"lat":326,"lon":327},52.48142,-1.89983,{"facility":329,"status":8,"city":330,"zip":331,"country":324,"geoPoint":332},"Royal Free Hospital - Haemophilia","London","NW3 2QG",{"lat":333,"lon":334},51.50853,-0.12574,{"facility":336,"status":8,"city":337,"zip":338,"country":324,"geoPoint":339},"Royal Hallamshire Hospital","Sheffield","S10 2JF",{"lat":340,"lon":341},53.38297,-1.4659,[343],{"name":344,"role":345,"phone":346,"email":347},"Novo Nordisk","CONTACT","(+1) 866-867-7178","clinicaltrials@novonordisk.com",[349],{"name":350,"affiliation":13,"role":351},"Clinical Transparency (dept. 2834)","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":355,"biomarkers":357},[356],"Hemophilia A",[358],"F8 wt Allele",{"nct_id":4,"found":78,"summary":360,"prompt_version":370},{"design":361,"status":362,"heading":363,"summary":364,"follow_up":365,"word_count":366,"commitments":367,"compensation":368,"drugs_mentioned":369},"This is an interventional study, meaning participants will receive the study medicine. It aims to enroll 30 participants.","completed","Research Study for Inno8 in Haemophilia A","This study is looking at how different doses of the medicine NNC0442-0344 A (also called Inno8) work in the bodies of men with haemophilia A. Haemophilia A is a genetic bleeding disorder where your blood doesn't clot properly. The main goal is to see if NNC0442-0344 A is safe for people with haemophilia A by tracking any side effects. To join, you must be a man between 18 and 64 years old, weigh at least 45 kilograms, and have a diagnosis of congenital haemophilia A with a factor VIII (FVIII) activity of 15% or less. This study plans to enroll 30 participants.","Participants will be followed from the time of dosing on Day 1 until the end of follow-up on Day 46.",102,"The study will last for about 11 weeks. NNC0442-0344 A will be given orally.","Not stated in the trial record.",[31],"v2"]