Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
Conditions
Brief summary
This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state. 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).
Interventions
DRUGactivated recombinant human factor VII
Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units) * Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product
Exclusion criteria
* Known or suspected allergy to trial product or any of its components or to related products * Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B * Platelet count below 50,000 platelets/mcL * Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TEG® (Thromboelastography) parameters after dosing of trial product | — |
| ROTEM® (Thromboelastometry) parameters after dosing of trial product | — |
Secondary
| Measure | Time frame |
|---|---|
| TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII | — |
| ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII | — |
| Serious adverse events and non-serious adverse events | — |
Countries
France, Germany, Israel
Outcome results
None listed