Status:
COMPLETED
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
12-66 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant fac...
Eligibility Criteria
Inclusion
- Japanese subjects who have completed NN7008-3543
- No detectable inhibitors to factor VIII
Exclusion
- Congenital or acquired coagulation disorders other than haemophilia A
- Planned surgery during the trial period
- Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01238367
Start Date
November 1 2010
End Date
October 1 2011
Last Update
February 10 2017
Active Locations (6)
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1
Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, Japan, 173 8606
2
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
3
Novo Nordisk Investigational Site
Maebashi-shi, Gunma, Japan, 371-8511
4
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023