Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A
NCT ID: NCT01205724
Last Updated: 2017-02-10
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
27 participants
INTERVENTIONAL
2010-09-30
2011-04-30
Brief Summary
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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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A
turoctocog alfa pegol
Single dose (low) administered intravenously (into the vein)
B
turoctocog alfa pegol
Single dose (medium) administered intravenously (into the vein)
C
turoctocog alfa pegol
Single dose (high) administered intravenously (into the vein)
Interventions
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turoctocog alfa pegol
Single dose (low) administered intravenously (into the vein)
turoctocog alfa pegol
Single dose (medium) administered intravenously (into the vein)
turoctocog alfa pegol
Single dose (high) administered intravenously (into the vein)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) below 35 kg/m2
* History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)
Exclusion Criteria
* Surgery planned to occur during the trial
* Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
* Congenital or acquired coagulation disorders other than haemophilia A
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
Iowa City, Iowa, United States
Novo Nordisk Investigational Site
Lexington, Kentucky, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Frankfurt/M., , Germany
Novo Nordisk Investigational Site
Giessen, , Germany
Novo Nordisk Investigational Site
Hanover, , Germany
Novo Nordisk Investigational Site
Florence, , Italy
Novo Nordisk Investigational Site
Vicenza, , Italy
Novo Nordisk Investigational Site
Kashihara-shi, Nara, , Japan
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, , Japan
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Zurich, , Switzerland
Novo Nordisk Investigational Site
Bornova-IZMIR, , Turkey (Türkiye)
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Manchester, , United Kingdom
Countries
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References
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Tiede A, Brand B, Fischer R, Kavakli K, Lentz SR, Matsushita T, Rea C, Knobe K, Viuff D. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013 Apr;11(4):670-8. doi: 10.1111/jth.12161.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2010-018520-68
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1116-2043
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-101293
Identifier Type: OTHER
Identifier Source: secondary_id
NN7088-3776
Identifier Type: -
Identifier Source: org_study_id
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