Conditions: Congenital Bleeding Disorder Haemophilia A Haemophilia B
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 51
Healthy volunteers: no

Brief summary:
This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.

The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: eptacog alfa (activated) intervention 2: vatreptacog alfa (activated) intervention 3: vatreptacog alfa (activated) intervention 4: vatreptacog alfa (activated) intervention 5: vatreptacog alfa (activated) intervention 6: vatreptacog alfa (activated)
Intervention descriptions: intervention 1: 90 mcg/kg, injected i.v. intervention 2: 5 mcg/kg, injected i.v. intervention 3: 10 mcg/kg, injected i.v. intervention 4: 20 mcg/kg, injected i.v. intervention 5: 40 mcg/kg, injected i.v. intervention 6: 80 mcg/kg, injected i.v.

Protocol document: