Congenital Haemophilia A or B of any severity with documented history of inhibitor
Conditions
Interventions
Patients were randomised to concizumab PPX or no PPX or assigned into the non-randomised treatment arms, based on their treatment regimen before entering the trial. After the restart of the trial, the
Sponsors
Novo Nordisk Pharma Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: '-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 at the time of signing informed consent. -Congenital Haemophilia A or B of any severity with documented history of inhibitor (>=0.6 BU). -Patient has been prescribed, or in need of, treatment with bypassing agents in the last 24 weeks prior to screening (for patients not previously enrolled in NN7415-4310 (explorer 4)).
Exclusion criteria
Exclusion criteria: '-Known or suspected hypersensitivity to any constituent of the trial product or related products. -Known inherited or acquired coagulation disorder other than congenital haemophilia. -Ongoing or planned Immune Tolerance Induction treatment. -History of thromboembolic disease. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of treated spontaneous and traumatic bleeding episodes | — |
Countries
Algeria, Australia, Austria, Bulgaria, Canada, Croatia, Czech Republic, Denmark, France, India, Italy, Japan, Malaysia, Mexico, Poland, Portugal, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States
Outcome results
None listed