Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A
NCT ID: NCT02994407
Last Updated: 2020-02-05
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
50 participants
INTERVENTIONAL
2017-01-30
2018-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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N8-GP s.c.
turoctocog alfa pegol
Part A: Participants will receive a single dose of turoctocog alfa pegol, administered subcutaneously (under the skin), at a dose of 12.5, 25 or 50 U/kg.
Part B: Participants will receive a daily dose of turoctocog alfa pegol, as identified in Part A, as a subcutaneous (under the skin) injection for a period of 3 months.
Interventions
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turoctocog alfa pegol
Part A: Participants will receive a single dose of turoctocog alfa pegol, administered subcutaneously (under the skin), at a dose of 12.5, 25 or 50 U/kg.
Part B: Participants will receive a daily dose of turoctocog alfa pegol, as identified in Part A, as a subcutaneous (under the skin) injection for a period of 3 months.
Eligibility Criteria
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Inclusion Criteria
* Male, age above or equal to 12 years at the time of signing informed consent,(part B).
* Diagnosis of congenital haemophilia A based on medical records (FVIII activity \<1%).
* History of more than 150 exposure days to any FVIII containing products.
Exclusion Criteria
(Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)
* Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load greater than or equal to 400.000 copies/mL and/or cluster of differentiation 4+ (CD4+) lymphocyte count less than or equal to 200/μL performed at screening or defined by medical records no older than 6 months)
* Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
* Inhibitors to FVIII (greater than or equal to 0.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.
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
Orlando, Florida, United States
Novo Nordisk Investigational Site
Iowa City, Iowa, United States
Novo Nordisk Investigational Site
East Lansing, Michigan, United States
Novo Nordisk Investigational Site
Cleveland, Ohio, United States
Novo Nordisk Investigational Site
Dayton, Ohio, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, United States
Novo Nordisk Investigational Site
Norfolk, Virginia, United States
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States
Novo Nordisk Investigational Site
Innsbruck, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Nantes, , France
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Duisburg, , Germany
Novo Nordisk Investigational Site
Homburg, , Germany
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Novi Sad, , Serbia
Countries
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References
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Klamroth R, Feistritzer C, Friedrich U, Lentz SR, Reichwald K, Zak M, Chowdary P. Pharmacokinetics, immunogenicity, safety, and preliminary efficacy of subcutaneous turoctocog alfa pegol in previously treated patients with severe hemophilia A (alleviate 1). J Thromb Haemost. 2020 Feb;18(2):341-351. doi: 10.1111/jth.14660. Epub 2019 Nov 15.
Other Identifiers
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U1111-1183-5111
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002396-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JapicCTI-173683
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN7170-4213
Identifier Type: -
Identifier Source: org_study_id
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