This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration
Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours
Unnamed facility
Madrid, Spain
Frequency of adverse events
Time frame: after 1 and 2 weeks after dosing
Frequency of serious adverse events
Time frame: after 1, 2 and 6-10 weeks after dosing
Frequency of MESIs (Medical Event of Special Interest)
Time frame: after 1, 2 and 6-10 weeks after dosing
Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa
Time frame: after 2 and 6-10 weeks after dosing
Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½
Time frame: from time of dosing up to 72 hours after the last dose
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