Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.

Official Title
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Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B 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
* Drug: activated recombinant human factor VII


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors Exclusion Criteria: Known hypersensitivity to activated recombinant human factor VII or any of its components Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment Clinical manifestation of active/recent bleeding Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration Body Mass Index (BMI) outside normal range Known abuse of elicit drugs and/or alcohol Renal insufficiency Hepatic disease Cardiovascular disease Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 55 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: Adults<br> | Drug: activated recombinant human factor VII<br>* A single bolus dose is administered. Injected intravenously<br>|
| Experimental: Paediatric<br> | Drug: activated recombinant human factor VII<br>* A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration curve from 0-12 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CL, the total body clearance |  |  | 
| Cmax, the maximum concentration |  |  | 
| tmax, the time to maximum concentration |  |  | 
| t1/2, the terminal half-life |  |  | 
| Area under the concentration curve from time 0-infinity |  |  | 
| Vss, the apparent volume of distribution at steady state |  |  | 
| Adverse events |  |  |