A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Haemophilia A
Спонсор: Novo Nordisk A/S
Налично на:
БГ
Обобщение
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.
Кой може да участва
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 or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.
Exclusion Criteria:
* 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/m\^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/or nutrients, as judged by the investigator.
Интервенции
NNC0442-0344 A
DRUG
Места на провеждане
33
Австрия (2)
Universitätsklinik für Innere Medizin V
Innsbruck
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna
Белгия (1)
Cliniques universitaires Saint-Luc
Brussels
NOT_YET_RECRUITING
Франция (1)
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique
Bron
NOT_YET_RECRUITING
Германия (3)
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie