Phase
Condition
Hemophilia
Treatment
NNC0442-0344 A
Clinical Study ID
Ages 18-64 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 orequal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medicalrecords.
Exclusion
Exclusion Criteria:
Current or prior exposure to any prophylactic treatment for haemophilia A within 5half-lives of the medicinal product by the time of screening.
Body mass index ≥30.0 kilogram per square meter (kg/m^2).
Increased risk of thrombosis, e.g. known history of personal or first-degreerelative(s) with unprovoked deep vein thrombosis.
Any clinical signs or established diagnosis of venous or arterial thromboembolicdisease.
Any known coagulation disorders other than haemophilia A.
Ongoing or planned immune tolerance induction therapy.
Presence of clinically significant gastrointestinal disorders potentially affectingabsorption of drugs and/or nutrients, as judged by the investigator.
Study Design
Connect with a study center
Universitätsklinik für Innere Medizin V
Innsbruck 2775220, 6020
AustriaActive - Recruiting
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna 2761369, 1090
AustriaActive - Recruiting
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin 2950159, 10249
GermanyActive - Recruiting
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie
Hanover 2910831, 30625
GermanyActive - Recruiting
AOU Careggi Firenze
Florence 3176959, 50134
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II di Napoli
Napoli 9031661, 80131
ItalyActive - Recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok 776069, 15-276
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk 3099434, 80-214
PolandActive - Recruiting
Instytut Hematologii i Transfuzjologii
Warsaw 756135, 02-776
PolandActive - Recruiting
Hospital Vall d'Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid 3117735, 28046
SpainActive - Recruiting
Hospital Regional Universitario de Málaga
Málaga 2514256, 29010
SpainActive - Recruiting
Hospital Clinico Universitario de Salamanca
Salamanca 3111108, 37007
SpainActive - Recruiting
West Midlands Adult Comprehensive Care Haemophilia
Birmingham 2655603, B15 2TH
United KingdomSite Not Available
Royal Free Haemophilia Comprehensive Care Centre
London 2643743, NW3 2QG
United KingdomActive - Recruiting
Royal Free Hospital - Haemophilia
London 2643743, NW3 2QG
United KingdomActive - Recruiting
Indiana Hemophilia-Thromb Ctr
Indianapolis 4259418, Indiana 4921868 46260
United StatesActive - Recruiting
University of Iowa_Iowa City
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
Penn State MS Hershey Med Ctr
Hershey 5193342, Pennsylvania 6254927 17033-2360
United StatesActive - Recruiting

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