Compassionate Use of Concizumab if You Have Haemophilia

Launched by NOVO NORDISK A/S · Jun 4, 2021

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Eligibility criteria

• Inclusion Criteria:
• • Informed consent obtained before any programme-related activities. Programme-related activities are any procedures that are carried out as part of the programme.
• * Patients with congenital haemophilia:
• • 1. severe haemophilia A (coagulation factor VIII (FVIII) less than 1%) or moderate/severe haemophilia B (coagulation factor IX (FIX) less than or equal to 2%) without inhibitors or
• • 2. any haemophilia severity with documented history of inhibitors (more than or equal to 0.6 bethesda unit (BU)) who cannot be treated satisfactorily with authorised and marketed medicines (example: due to inhibitors or allergic reactions to factor-containing products, or due to poor venous access), and who are not able to enrol in clinical trials designed to support the development and registration of concizumab medicines (example: due to inhibitors or allergic reactions to factor-containing products, or due to poor venous access) as per investigator and Novo Nordisk assessment.
• • The potential benefit for the individual patient justifies the potential risks of treatment.
• Exclusion Criteria:
• • Known or suspected hypersensitivity to investigational medicinal product or related products.
• • Any condition (current or medical history), which in the investigator's or Novo Nordisk's opinion might jeopardise patient's safety or compliance with the protocol.