Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.

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

Details

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

Criteria

Inclusion Criteria:

• Severe haemophilia A (FVIII level less than or equal to 1%)

• Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products

• HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial

Exclusion Criteria:

• Presence of any bleeding disorder in addition to haemophilia A

• Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor

• Abnormal renal function tests

• Known hypersensitivity to Advate®