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
NCT ID: NCT02920398
Last Updated: 2017-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2016-10-04
2017-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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N8-GP pivotal
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.
N8-GP commercial
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2015-005327-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1176-9253
Identifier Type: OTHER
Identifier Source: secondary_id
NN7088-4033
Identifier Type: -
Identifier Source: org_study_id