Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors - explorer8

OVO NORDISK. S.P.A.0 个研究点目标入组 158 人开始时间: 2021年6月15日最近更新: 2024年1月8日

试验速览

暂无简介。

•- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•- Male aged 12 years or older at the time of signing informed consent.
•- Congenital severe haemophilia A (FVIII less than 1%) or moderate/severe B (FIX 2% or less)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 113
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Known or suspected hypersensitivity to any constituent of the trial product or related products
•- Known inherited or acquired coagulation disorder other than congenital haemophilia
•- Presence of confirmed inhibitors 0.6 BU or greater at screening
•- History of thromboembolic disease (includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion). Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events (thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events).

发起方

OVO NORDISK. S.P.A.