A multi-centre, randomised, placebo controlled, double blinded, multiple dose trial investigating safety, pharmacokinetics and pharmacodynamics of concizumab administered subcutaneously to haemophilia A subjects
Withdrawn
- Conditions
- 10064477blood clotting disorderHaemophilia A
- Registration Number
- NL-OMON42365
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 3
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>- Number of adverse events (AEs) from first trial drug administration (day 1)<br /><br>to 11 weeks after the first trial product administration.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary endpoints:<br /><br>- Trough level of concizumab prior to the last subcutaneous dose administration<br /><br>(day 42).<br /><br>- Frequency of binding non-neutralizing anti-concizumab antibodies from first<br /><br>trial drug administration (day 1) to 11 weeks after the first trial product<br /><br>administration.</p><br>