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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 | Clinical Trials | Clareo Health

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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

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

NCT01562587•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

3 - 55 years

Sex

MALE

Healthy Volunteers

No

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
+1 more criteria

Locations (8)

Novo Nordisk Investigational Site

Bremen, Germany

Novo Nordisk Investigational Site

Frankfurt, Germany

Novo Nordisk Investigational Site

Athens, Greece

Novo Nordisk Investigational Site

Florence, Italy

Novo Nordisk Investigational Site

Milan, Italy

Novo Nordisk Investigational Site

Madrid, Spain

Novo Nordisk Investigational Site

London, United Kingdom

Novo Nordisk Investigational Site

Oxford, United Kingdom

Key Dates

Start Date

September 1, 2002

Primary Completion Date

May 1, 2003

Completion Date

May 1, 2003

Last Updated

January 12, 2017

Enrollment

18

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia B

Interventions

activated recombinant human factor VII

DRUG

activated recombinant human factor VII

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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