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 (pathfinder™7)

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: turoctocog alfa pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT02920398

NN7088-4033

U1111-1176-9253 (Other Identifier)

2015-005327-63 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

21 patients

Sex

Male

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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