Compassionate Use of Concizumab if You Have Haemophilia
- Conditions
- Congenital Haemophilia
- Registration Number
- NCT04921956
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Available
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Informed consent obtained before any programme-related activities. Programme-related<br> activities are any procedures that are carried out as part of the programme.<br><br> - Patients with congenital haemophilia:<br><br> 1. severe haemophilia A (coagulation factor VIII (FVIII) less than 1%) or<br> moderate/severe haemophilia B (coagulation factor IX (FIX) less than or equal<br> to 2%) without inhibitors or<br><br> 2. any haemophilia severity with documented history of inhibitors (more than or<br> equal to 0.6 bethesda unit (BU)) who cannot be treated satisfactorily with<br> authorised and marketed medicines (example: due to inhibitors or allergic<br> reactions to factor-containing products, or due to poor venous access), and who<br> are not able to enrol in clinical trials designed to support the development<br> and registration of concizumab medicines (example: due to inhibitors or<br> allergic reactions to factor-containing products, or due to poor venous access)<br> as per investigator and Novo Nordisk assessment.<br><br> - The potential benefit for the individual patient justifies the potential risks of<br> treatment.<br><br>Exclusion Criteria:<br><br> - Known or suspected hypersensitivity to investigational medicinal product or related<br> products.<br><br> - Any condition (current or medical history), which in the investigator's or Novo<br> Nordisk's opinion might jeopardise patient's safety or compliance with the protocol.
Not provided
Study & Design
- Study Type
- Expanded Access
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method