blood clotting disorder Haemophilia A
Conditions
Interventions
Continued treatment with N8-GP according to treatment regime in pathfinder2
trial in the period prior to the surgery. An initial injection with N8-GP on
the day of surgery, and afterwards depending
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Ongoing participation in the pathfinder2 (NN7088-3859) trial and having received *5 doses of N8-GP - Undergoing major surgery
Exclusion criteria
Exclusion criteria: - Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products - Previous withdrawal from the pathfinder2 (NN7088-3859) trial after administration of trial product, except interruption due to inclusion in this pathfinder3 trial (NN7088-3860) - The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. - FVIII inhibitors * 0.6 BU/mL at screening - Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records) - Immune modulating or chemotherapeutic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: * Haemostatic effect during surgery evaluated by the four-point scale (excellent, good, moderate or none), assessed by the Investigator/surgeon at the day of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: * Average consumption of N8-GP during surgery * Haemostatic effect of N8-GP during the post-operative period Days 1-6 and 7-14 * Average consumption of N8-GP during the post-operative period Days 1-6 * Incidence rate of inhibitors against factor VIII (FVIII) (*0.6 BU/mL) | — |
Countries
Netherlands
Outcome results
None listed