Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State

Study Overview
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Brief Summary
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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).

Official Title
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A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State

Conditions
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Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Intervention / Treatment
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* Drug: activated recombinant human factor VII


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br> | Drug: activated recombinant human factor VII<br>* Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)<br>|
| Experimental: Medium dose<br> | Drug: activated recombinant human factor VII<br>* Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)<br>|
| Experimental: High dose<br> | Drug: activated recombinant human factor VII<br>* Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEG® (Thromboelastography) parameters after dosing of trial product |  |  | 
| ROTEM® (Thromboelastometry) parameters after dosing of trial product |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  |