Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

September 1, 2009

Primary Completion Date

March 29, 2011

Study Completion Date

March 29, 2011

Conditions
Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors
Interventions
DRUG

activated recombinant human factor VII, long acting

After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 25 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months

DRUG

activated recombinant human factor VII, long acting

After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 100 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months

DRUG

activated recombinant human factor VII, long acting

After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 200 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months

Trial Locations (25)

2193

Novo Nordisk Investigational Site, Parktown Johannesburg

4013

Novo Nordisk Investigational Site, Durban

11000

Novo Nordisk Investigational Site, Belgrade

Novo Nordisk Investigational Site, Belgrade

17033

Novo Nordisk Investigational Site, Hershey

33607

Novo Nordisk Investigational Site, Tampa

34098

Novo Nordisk Investigational Site, Istanbul

50400

Novo Nordisk Investigational Site, Kuala Lumpur

72202

Novo Nordisk Investigational Site, Little Rock

75015

Novo Nordisk Investigational Site, Paris

90027

Novo Nordisk Investigational Site, Los Angeles

92868

Novo Nordisk Investigational Site, Orange

94270

Novo Nordisk Investigational Site, Le Kremlin-Bicêtre

97239

Novo Nordisk Investigational Site, Portland

02115

Novo Nordisk Investigational Site, Boston

20211-030

Novo Nordisk Investigational Site, Rio de Janeiro

634 8522

Novo Nordisk Investigational Site, Kashihara-shi, Nara

807 8555

Novo Nordisk Investigational Site, Kitakyusyu, Fukuoka

663 8051

Novo Nordisk Investigational Site, Nishinomiya-shi

160 0023

Novo Nordisk Investigational Site, Shinjuku-ku, Tokyo

205 02

Novo Nordisk Investigational Site, Malmo

06500

Novo Nordisk Investigational Site, Ankara

NW3 2QG

Novo Nordisk Investigational Site, London

SE1 7EH

Novo Nordisk Investigational Site, London

OX3 7LJ

Novo Nordisk Investigational Site, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY