Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

• Status: Completed
• Trial end date: 2017-06-20
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.

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

Details

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

Criteria

Inclusion Criteria:

• Male, age at least 18 years at the time of signing informed consent

• History of more than 150 exposure days to any factor VIII products

• Subjects with the diagnosis of congenital haemophilia A with factor VIII activity below 1%, based on medical records

Exclusion Criteria:

• Known history of factor VIII inhibitors

• Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening measured by the Nijmegen modified Bethesda method

• Known congenital or acquired coagulation disorders other than haemophilia A

• Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial