A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Congenital Bleeding DisorderHaemophilia A
Interventions
DRUG

turoctocog alfa

Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.

Trial Locations (6)

1670035

Novo Nordisk Investigational Site, Suginami-ku, Tokyo

4208660

Novo Nordisk Investigational Site, Shizuoka-shi, Shizuoka

173 8606

Novo Nordisk Investigational Site, Itabashi-ku, Tokyo

634 8522

Novo Nordisk Investigational Site, Kashihara-shi, Nara

371-8511

Novo Nordisk Investigational Site, Maebashi-shi, Gunma

160 0023

Novo Nordisk Investigational Site, Shinjuku-ku, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01238367 - A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 | Biotech Hunter | Biotech Hunter