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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01562587

Enrollment

Registered

2012-03-26

Start date

2002-09-30

Completion date

2003-05-31

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Brief summary

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.

Interventions

DRUGactivated recombinant human factor VII

A single bolus dose is administered. Injected intravenously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

3 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under the concentration curve from 0-12 hours	—

Secondary

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

Countries

Germany, Greece, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026