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

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 30, 2002

Primary Completion Date

May 31, 2003

Study Completion Date

May 31, 2003

Conditions
Congenital Bleeding DisorderHaemophilia AHaemophilia B
Interventions
DRUG

activated recombinant human factor VII

A single bolus dose is administered. Injected intravenously

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

Trial Locations (8)

20124

Novo Nordisk Investigational Site, Milan

28046

Novo Nordisk Investigational Site, Madrid

28205

Novo Nordisk Investigational Site, Bremen

50134

Novo Nordisk Investigational Site, Florence

60590

Novo Nordisk Investigational Site, Frankfurt

GR-11527

Novo Nordisk Investigational Site, Athens

WC1N 3JH

Novo Nordisk Investigational Site, London

OX3 7LJ

Novo Nordisk Investigational Site, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY