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

Completed · Phase 1

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

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

Key facts

Study ID

NCT02920398

Run by

Novo Nordisk A/S

People needed

21

Starts

2016-10-04

Expected to finish

2017-04-07

Last updated by the study team

2017-12-15

Who can join

Age: 12 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Ongoing participation in pathfinder™2
• Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)

You may not qualify if…

• FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
• Planned surgery during the trial
• Major surgery performed within 4 weeks prior to screening
• Previous participation in this trial. Participation is defined as signed informed consent
• Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol

Where it is running

• Novo Nordisk Investigational Site — Torrance, California, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Nashville, Tennessee, United States
• Novo Nordisk Investigational Site — Århus N, Denmark
• Novo Nordisk Investigational Site — Bron, France
• Novo Nordisk Investigational Site — Nantes, France
• Novo Nordisk Investigational Site — Berlin, Germany
• Novo Nordisk Investigational Site — Frankfurt/M., Germany
• Novo Nordisk Investigational Site — Homburg, Germany
• Novo Nordisk Investigational Site — Groningen, Netherlands
• Novo Nordisk Investigational Site — Madrid, Spain
• Novo Nordisk Investigational Site — Málaga, Spain

Full record on ClinicalTrials.gov

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