Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography

The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a
(a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM
parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum
Clot Firmness) and LI60 (Lysis index 60 min after CT)

Inclusion Criteria:

- Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C clot activity or
FIX:C clot activity, respectively, less than 5%

- Presently use of activated recombinant human factor VII (NovoSeven®) as haemostatic
agent for preventive treatment or treatment of bleeding episodes

- A documented historical or present record for the presence of inhibitors to factor
VIII or IX, respectively

- A documented history of 2 or more joint bleeding episodes during the preceding 12
months

- Subjects must be in a non-bleeding state (i.e. no clinical manifestations of active
bleeds)

Exclusion Criteria:

- Subjects who have received any haemostatic treatment for a bleeding episode within
the last 7 days prior to this trial

- Immune tolerance therapy within the last 30 days prior to this trial

- Clinically relevant coagulation disorders other than congenital haemophilia A or B

- Thrombocytopenia (platelet count below 60,000 platelets/mcl)

- Prophylactic haemostatic treatment within 3 days prior to this trial