Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

Inclusion Criteria: - Male patients with severe congenital haemophilia A (FVIII activity
below 1%, according to medical records) - Documented history of at least 150 EDs (exposure
days) to other FVIII products - At least 12 years and body weight at least 35 kg (except
for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be
18 years) Exclusion Criteria: - Previous participation in this trial defined as withdrawal
after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or
equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by
medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral
load of more than 400000 copies/mL. If the data is not available in medical records within
last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired
coagulation disorders other than haemophilia A - Previous significant thromboembolic events
(e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined
by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value
at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of
normal reference ranges at central laboratory - Creatinine level equal to or greater than
1.5 times above upper normal limit (according to central laboratory reference ranges) -
Ongoing immune modulating or chemotherapeutic medication