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

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Factor VIII

Criteria

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