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Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors
To establish the effect and investigate safety of daily subcutaneous treatment with concizumab prophylaxis when given to adult and adolescent haemophilia patients without inhibitors.
There will be approximate 28 in person visits with blood drawn at 27of these.
Bree Kelly - at jhawthorne@pennstatehealth.psu.edu or 717-531-0003, ext=281498
Male
All
NCT04082429
STUDY00013127
Inclusion Criteria:
Male aged ≥12 yearsBody weight >25 kg at screening
Congenital severe haemophilia A (FVIII < 1%) or moderate/severe B (FIX ≤ 2%)
Documented treatment with coagulation factor containing product in the last 24 weeks
Exclusion Criteria:
Treatment with emicizumab within 180 days before screeningParticipation in any clinical trial of an approved or non-approved investigational product within 5 half-lives or 30 days from screening
Known or suspected hypersensitivity to monoclonal antibodies
History of thromboembolic disease
inhibitors ≥0.6 BU in the last 5 years
Blood Disorders