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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-05-31

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.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adults

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

A single bolus dose is administered. Injected intravenously

Paediatric

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

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

Interventions

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activated recombinant human factor VII

A single bolus dose is administered. Injected intravenously

Intervention Type DRUG

activated recombinant human factor VII

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

Intervention Type DRUG

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No