A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).

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

Details

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

Criteria

Inclusion Criteria:

• Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)

• Body weight between 10 to 120 kg

• Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)

Exclusion Criteria:

• Known or suspected hypersensitivity to trial product(s) or related products

• Previous participation in this trial defined as withdrawal

• Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)

• Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome