Status:
COMPLETED
Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII 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 is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated f...
Eligibility Criteria
Inclusion
- Signed Informed Consent by subject's parents or subject's legally acceptable representative before any trial related activities. Trial related activities are any procedures that would not have been performed during the normal management of the subject
- 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
- Known antibodies to FXIII
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01230021
Start Date
November 1 2010
End Date
January 1 2012
Last Update
February 24 2017
Active Locations (10)
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1
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02115
2
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48201
3
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55404
4
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43205