Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Congenital Bleeding DisorderHaemophilia B
Interventions
DRUG

nonacog beta pegol

Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)

DRUG

nonacog beta pegol

Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)

DRUG

nonacog beta pegol

Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)

Trial Locations (19)

2100

Novo Nordisk Investigational Site, Copenhagen

10249

Novo Nordisk Investigational Site, Berlin

23219

Novo Nordisk Investigational Site, Richmond

28046

Novo Nordisk Investigational Site, Madrid

30625

Novo Nordisk Investigational Site, Hanover

45229

Novo Nordisk Investigational Site, Cincinnati

53127

Novo Nordisk Investigational Site, Bonn

60590

Novo Nordisk Investigational Site, Frankfurt/M.

69003

Novo Nordisk Investigational Site, Lyon

94270

Novo Nordisk Investigational Site, Le Kremlin-Bicêtre

97239

Novo Nordisk Investigational Site, Portland

634 8522

Novo Nordisk Investigational Site, Kashihara-shi, Nara

466 8560

Novo Nordisk Investigational Site, Nagoya-shi, Aichi

663 8051

Novo Nordisk Investigational Site, Nishinomiya-shi

171 76

Novo Nordisk Investigational Site, Stockholm

NW3 2QG

Novo Nordisk Investigational Site, London

SE1 7EH

Novo Nordisk Investigational Site, London

M13 9WL

Novo Nordisk Investigational Site, Manchester

OX3 7LJ

Novo Nordisk Investigational Site, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT00956345 - Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B | Biotech Hunter | Biotech Hunter