Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors
- Conditions
- Congenital Haemophilia A or B of any severity with documented history of inhibitor
- Registration Number
- JPRN-jRCT2080224957
- Lead Sponsor
- ovo Nordisk Pharma Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 160
'-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)).
'-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method