blood clotting disorder Haemophilia A
Conditions
Interventions
Trial products will be administered subcutaneously in the abdominal area under
the surveillance of medically trained trial site staff on day 1 and 2, and
subsequently every 4th day.
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand. - Subjects with a baseline level of factor VIII * 2 % based on medical records. - Age between 18 and 64 years both inclusive, at the time of signing informed consent - Body weight between 50 and 100 kg, both inclusive.
Exclusion criteria
Exclusion criteria: - Known or suspected hypersensitivity to trial product or related products. - Platelet count below 50x10^9/L at screening. - Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator. - Subjects at increased risk of cardiovascular disease as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: - Number of adverse events (AEs) from first trial drug administration (day 1) to 11 weeks after the first trial product administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints: - Trough level of concizumab prior to the last subcutaneous dose administration (day 42). - Frequency of binding non-neutralizing anti-concizumab antibodies from first trial drug administration (day 1) to 11 weeks after the first trial product administration. | — |
Countries
Netherlands
Outcome results
None listed