Status:
COMPLETED
Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Congenital FXIII Deficiency
Eligibility:
All Genders
1-6 years
Phase:
PHASE3
Brief Summary
This trial will be conducted in Asia, Europe and the United States of America (USA). The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bl...
Eligibility Criteria
Inclusion
- Completed participation in trial F13CD-3760 (NCT01230021)
Exclusion
- Known or suspected hypersensitivity to trial product or related products
- Known history of development of inhibitors against FXIII (factor XIII)
- Hereditary or acquired coagulation disorder other than FXIII congenital deficiency
- Platelet count (thrombocytes) less than 50X10e9 / L
- 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
- Any disease or condition which, judged by the trial physician, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome including renal and/or liver dysfunction
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01253811
Start Date
January 1 2011
End Date
March 1 2015
Last Update
June 24 2016
Active Locations (4)
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1
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02115
2
Novo Nordisk Clinical Trial Call Center
Columbus, Ohio, United States, 43205
3
Petah Tikva, Israel, 49100
4
Leicester, United Kingdom, LE1 5WW