NN7088-3860 – Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients with Haemophilia A

Service: Trial Number:
138-12
Principal Investigator: Conducted at:
Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes

The primary purpose of this research trial is to evaluate the hemostatic effect, (shortens the clotting time of blood), of N8-GP during surgical procedures in patients with haemophilia A. The secondary purposes are to evaluate the general safety including immunogenicity, the quality of relating to a bodily system that protects the body from foreign substances, cells, and tissues, of N8-GP when used for prevention and treatment of bleeding throughout the surgical period and to evaluate the hemostatic effect of N8-GP during the postoperative period. Finally, to evaluate health economic resource use (hospitalization days) due to surgery. The trial is a multi-centre, multi-national, open-label, non-randomized, single arm, efficacy and safety trial evaluating N8 GP during surgical procedures in patients with severe FVIII haemophilia A. Patients from the Pathfinder 2 trial (MHS Project 064-12) will be recruited to enroll in this study (Pathfinder 3) only having received 5 doses of N8-GP. Upon completion of this study, patients will return to Pathfinder 2, re-entering the prophylactic treatment arm as per their prior participation in the trial. All patients in Pathfinder 2 will be offered to enter this trial in case they need major surgery.

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