Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
Conditions
Brief summary
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.
Interventions
Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Haemophilia A or B * Bodyweight max 100 kg * Body Mass Index (BMI) max 30 kg/m2 * Adequate venous access
Exclusion criteria
* Known or suspected allergy to trial product(s) or related products (including NovoSeven®) * The receipt of any investigational product within 30 days prior to enrolment in this trial * Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial * The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product * Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration * Known pseudo tumours * Congenital or acquired coagulation disorders other than haemophilia A or B * Any major and/or orthopaedic surgery within one month prior to trial start * Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.) * Clinical signs of renal dysfunction * Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug * Use of non-prescribed opiate substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events | after 1 and 2 weeks after dosing |
| Frequency of serious adverse events | after 1, 2 and 6-10 weeks after dosing |
| Frequency of MESIs (Medical Event of Special Interest) | after 1, 2 and 6-10 weeks after dosing |
| Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa | after 2 and 6-10 weeks after dosing |
Secondary
| Measure | Time frame |
|---|---|
| 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 | from time of dosing up to 72 hours after the last dose |
Countries
Spain
Outcome results
None listed