A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
NCT ID: NCT01731600
Last Updated: 2020-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
68 participants
INTERVENTIONAL
2013-02-20
2018-09-28
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
turoctocog alfa pegol
Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.
Interventions
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turoctocog alfa pegol
Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII products for patients aged 6-11 years and above 50 ED to FVIII products for patients aged 0-5 years
Exclusion Criteria
0 Years
11 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
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Novo Nordisk Investigational Site
Orange, California, United States
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, United States
Novo Nordisk Investigational Site
Orlando, Florida, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Boise, Idaho, United States
Novo Nordisk Investigational Site
Iowa City, Iowa, United States
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
Novo Nordisk Investigational Site
New Hyde Park, New York, United States
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Dayton, Ohio, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, United States
Novo Nordisk Investigational Site
Nashville, Tennessee, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Charlottesville, Virginia, United States
Novo Nordisk Investigational Site
Spokane, Washington, United States
Novo Nordisk Investigational Site
Rio de Janeiro, , Brazil
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Novo Nordisk Investigational Site
Bron, , France
Novo Nordisk Investigational Site
Lille, , France
Novo Nordisk Investigational Site
Paris, , France
Novo Nordisk Investigational Site
Athens, , Greece
Novo Nordisk Investigational Site
Thessaloniki, , Greece
Novo Nordisk Investigational Site
Tel Litwinsky, , Israel
Novo Nordisk Investigational Site
Vicenza, , Italy
Novo Nordisk Investigational Site
Kitakyusyu, Fukuoka, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Vilnius, , Lithuania
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Porto, , Portugal
Novo Nordisk Investigational Site
San Juan, , Puerto Rico
Novo Nordisk Investigational Site
Bellinzona, , Switzerland
Novo Nordisk Investigational Site
Lucerne, , Switzerland
Novo Nordisk Investigational Site
Zurich, , Switzerland
Novo Nordisk Investigational Site
Antalya, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Bornova-IZMIR, , Turkey (Türkiye)
Novo Nordisk Investigational Site
İzmit, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Samsun, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Donetsk, , Ukraine
Novo Nordisk Investigational Site
Lviv, , Ukraine
Novo Nordisk Investigational Site
Leicester, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Oxford, , United Kingdom
Countries
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References
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Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes L, Sathar J, Meijer K, Chowdary P, Shen C, Landorph A, Hampton K. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia. 2020 May;26(3):450-458. doi: 10.1111/hae.13980. Epub 2020 Apr 15.
Saulyte Trakymiene S, Economou M, Kenet G, Landorph A, Shen C, Kearney S. Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5. J Thromb Haemost. 2020 Sep;18 Suppl 1(Suppl 1):15-25. doi: 10.1111/jth.15036.
Provided Documents
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Document Type: Study Protocol
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1129-6009
Identifier Type: OTHER
Identifier Source: secondary_id
2012-001711-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JapicCTI-132214
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN7088-3885
Identifier Type: -
Identifier Source: org_study_id