Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency
NCT ID: NCT01230021
Last Updated: 2017-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
6 participants
INTERVENTIONAL
2010-11-30
2012-01-31
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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recombinant factor XIII
catridecacog
Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg bodyweight
Interventions
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catridecacog
Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg bodyweight
Eligibility Criteria
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Inclusion Criteria
* Age 1 to less than 6 years old at the time of enrolment
* Congenital FXIII subunit-A deficiency previously documented by genotyping or evaluated by genotyping through blood sampling at screening visit
* Body weight at least 10 kg
Exclusion Criteria
* Hereditary or acquired coagulation disorder other than FXIII A-subunit congenital deficiency
* Platelet count (thrombocytes) of less than 50 × 10\^9/L (at screening visit)
* Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus
* Previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis
* Known or suspected allergy to trial product or related products
* Any surgical procedure in the 30 days prior to enrolment and any planned surgery during the trial period
* Any disease or condition which, judged by the Investigator, could imply a potential hazard to the subject or interfere with the trial participation or trial outcome including renal and/or liver dysfunction
1 Year
6 Years
ALL
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
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
Detroit, Michigan, United States
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States
Novo Nordisk Investigational Site
Columbus, Ohio, United States
Novo Nordisk Investigational Site
Petah Tikva, , Israel
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
Novo Nordisk Investigational Site
Leicester, , United Kingdom
Novo Nordisk Investigational Site
Manchester, , United Kingdom
Novo Nordisk Investigational Site
Newcastle upon Tyne, , United Kingdom
Novo Nordisk Investigational Site
Reading, , United Kingdom
Countries
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References
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Williams M, Will A, Stenmo C, Rosholm A, Tehranchi R. Pharmacokinetics of recombinant factor XIII in young children with congenital FXIII deficiency and comparison with older patients. Haemophilia. 2014 Jan;20(1):99-105. doi: 10.1111/hae.12224. Epub 2013 Jul 9.
Brand-Staufer B, Carcao M, Kerlin BA, Will A, Williams M, Tornoe CW, Sandberg Lundblad M, Nugent D. Pharmacokinetic characterization of recombinant factor XIII (FXIII)-A2 across age groups in patients with FXIII A-subunit congenital deficiency. Haemophilia. 2015 May;21(3):380-385. doi: 10.1111/hae.12616. Epub 2015 Jan 21.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1116-2533
Identifier Type: OTHER
Identifier Source: secondary_id
2009-016869-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
F13CD-3760
Identifier Type: -
Identifier Source: org_study_id
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