Brief Title
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
Official Title
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.
Brief 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
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area under the FVIII activity-time curve
Secondary Outcome
FVIII activity 30 min post administration - dose normalised to 50 U/kg
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa pegol
Study Arms / Comparison Groups
N8-GP pivotal
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
21
Start Date
October 4, 2016
Completion Date
April 7, 2017
Primary Completion Date
April 7, 2017
Eligibility Criteria
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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT02920398
Organization ID
NN7088-4033
Secondary IDs
2015-005327-63
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
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Verification Date
December 2017