Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
NCT ID: NCT00978380
Last Updated: 2018-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
63 participants
INTERVENTIONAL
2009-09-21
2015-10-20
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
PREVENTION
NONE
Study Groups
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A
catridecacog
Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)
Interventions
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catridecacog
Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous participation (means up to and inclusive Visit 16, (End of Trial)) in F13CD-1725
* For all other subjects:
* Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit or documented results from previously performed genotyping)
* Body weight at least 20 kg
Exclusion Criteria
* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
* Platelet count (thrombocytes) of less than 50 × 109/L. For subjects who participated in F13CD-1725 platelet count from visit 15 in F13CD-1725 must be used for evaluation.
* Females of childbearing potential who are pregnant, breastfeeding or are not using adequate contraceptive methods
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
Orange, California, United States
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Boise, Idaho, 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
Oklahoma City, Oklahoma, United States
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States
Novo Nordisk Investigational Site
Richmond, Virginia, United States
Novo Nordisk Investigational Site
Seattle, Washington, United States
Novo Nordisk Investigational Site
Klagenfurt, , Austria
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, , France
Novo Nordisk Investigational Site
Paris, , France
Novo Nordisk Investigational Site
Rouen, , France
Novo Nordisk Investigational Site
Valence, , France
Novo Nordisk Investigational Site
Bonn, , Germany
Novo Nordisk Investigational Site
Braunschweig, , Germany
Novo Nordisk Investigational Site
Duisburg, , Germany
Novo Nordisk Investigational Site
Petah Tikva, , Israel
Novo Nordisk Investigational Site
Vicenza, , Italy
Novo Nordisk Investigational Site
Hiroshima-shi, Hiroshima, , Japan
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Barcelona, , Spain
Novo Nordisk Investigational Site
Málaga, , Spain
Novo Nordisk Investigational Site
Tortosa, , Spain
Novo Nordisk Investigational Site
Zurich, , Switzerland
Novo Nordisk Investigational Site
Aberdeen, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Manchester, , United Kingdom
Novo Nordisk Investigational Site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
Kerlin B, Brand B, Inbal A, Halimeh S, Nugent D, Lundblad M, Tehranchi R. Pharmacokinetics of recombinant factor XIII at steady state in patients with congenital factor XIII A-subunit deficiency. J Thromb Haemost. 2014 Dec;12(12):2038-43. doi: 10.1111/jth.12739. Epub 2014 Oct 25.
Byrnes JR, Lee T, Sharaby S, Campbell RA, Dobson DA, Holle LA, Luo M, Kangro K, Homeister JW, Aleman MM, Luyendyk JP, Kerlin BA, Dumond JB, Wolberg AS. Reciprocal stabilization of coagulation factor XIII-A and -B subunits is a determinant of plasma FXIII concentration. Blood. 2024 Feb 1;143(5):444-455. doi: 10.1182/blood.2023022042.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-007883-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1111-9289
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-121958
Identifier Type: REGISTRY
Identifier Source: secondary_id
F13CD-3720
Identifier Type: -
Identifier Source: org_study_id
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