A prospective, multicenter, open-label clinical trial with two randomized and two non-randomized study arms. The aim of the study is to evaluate the effect and safety of daily concizumab prophylaxis s.c. in patients with hemophilia without inhibitors.
Aim of the study
The aim of this phase 3 study is to evaluate the efficacy and safety of daily subcutaneous treatment with concizumab for prophylaxis in adult and adolescent hemophilia patients without inhibitors.
Who can take part?
Patients with hemophilia A or B without inhibitors
Procedure
After screening, patients are randomized or assigned to non-randomized treatment arms according to their treatment prior to the study. The study consists of a main part (24 or 32 weeks), an extension part (up to 265 weeks) and a safety control part (7 weeks). The duration of the extension phase will vary for patients depending on the timing of randomization or allocation and when concizumab is commercially available in their country.
Compensation
Original study name
Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors (Explorer 8)
BASEC number
2021-01593
Financial support from