NCT02920398

A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A

This Trial is Conducted in Europe and the United States of America. The Aim of This Trial is to Investigate Single Dose Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa pegol	Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.

Timeline

• Start date: 2016-10-04
• Primary completion: 2017-04-07
• Completion: 2017-04-07
• First posted: 2016-09-30
• Last updated: 2017-12-15

Locations

14 sites across 6 countries: United States, Denmark, France, Germany, Netherlands, Spain

Regulatory

• FDA-regulated drug study