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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Male

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 factor VIII (N8)) in Japanese subjects with haemophilia A.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Japanese subjects who have completed NN7008-3543

• No detectable inhibitors to factor VIII

Exclusion Criteria:

• 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