Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B
NCT ID: NCT00956345
Last Updated: 2017-01-20
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
18 participants
INTERVENTIONAL
2009-08-31
2010-07-31
Brief Summary
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The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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25U/kg
nonacog beta pegol
Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
50U/kg
nonacog beta pegol
Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)
100U/kg
nonacog beta pegol
Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)
Interventions
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nonacog beta pegol
Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
nonacog beta pegol
Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)
nonacog beta pegol
Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of at least 150 exposure days to any Factor IX products
* Body Mass Index (BMI) below 30.0 kg/m2 (inclusive)
Exclusion Criteria
* Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
* Kidney or liver dysfunction
* Scheduled surgery requiring Factor IX replacement therapy, during the trial period
18 Years
65 Years
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Portland, Oregon, United States
Novo Nordisk Investigational Site
Richmond, Virginia, United States
Novo Nordisk Investigational Site
Copenhagen, , Denmark
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, , France
Novo Nordisk Investigational Site
Lyon, , France
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Bonn, , Germany
Novo Nordisk Investigational Site
Frankfurt/M., , Germany
Novo Nordisk Investigational Site
Hanover, , Germany
Novo Nordisk Investigational Site
Kashihara-shi, Nara, , Japan
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, , Japan
Novo Nordisk Investigational Site
Nishinomiya-shi, , Japan
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Stockholm, , Sweden
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Manchester, , United Kingdom
Novo Nordisk Investigational Site
Oxford, , United Kingdom
Countries
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References
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Negrier C, Knobe K, Tiede A, Giangrande P, Moss J. Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B. Blood. 2011 Sep 8;118(10):2695-701. doi: 10.1182/blood-2011-02-335596. Epub 2011 May 9.
Collins PW, Moss J, Knobe K, Groth A, Colberg T, Watson E. Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost. 2012 Nov;10(11):2305-12. doi: 10.1111/jth.12000.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2009-011085-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
090857
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN7999-3639
Identifier Type: -
Identifier Source: org_study_id
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