Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State
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About
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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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