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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Haemophilia B

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: activated recombinant human factor VII

Study type

Interventional

Funder types

Industry

Identifiers

NCT01562587

F7HAEM-1503

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

Male

Ages

3 to 55 years old

Volunteers

No 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