This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)
Subject will receive 3 injections (i.v.) of 90 microg/kg rFVIIa (NovoSeven®) over a 6 hour period (each injection will be separated by 3 hours)
Unnamed facility
Madrid, Spain
Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')
Time frame: 10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg
TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA)
Time frame: Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/kg
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