A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Deficiency

ovo Nordisk A/S0 个研究点目标入组 6 人开始时间: 2010年7月7日最近更新: 2019年11月25日

适应症

试验速览

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•1. 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
•2. Age 1 to less than 6 years old at the time of enrolment
•3. Congenital FXIII subunit-A deficiency previously documented by genotyping or evaluated by genotyping through blood sampling at screening visit
•4. Body weight = 10 kg
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Received blood products or FXIII concentrates within 4 weeks of trial product administration
•2. Known antibodies to FXIII
•3. Previous participation in this trial. Participation is defined as dosed and withdrawn
•4. Hereditary or acquired coagulation disorder other than FXIII A-subunit congenital deficiency
•5. Platelet count (thrombocytes) < 50 × 10 9/L (at screening visit)
•6. Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus
•7. Previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis
•8. Administration of any antithrombotic or antiplatelet drugs within 7 days of trial enrolment
•9. Known or suspected allergy to trial product or related products
•10. Received treatment with any experimental agent within 30 days of trial enrolment
•11. Any concurrent serious chronic or acute illness or infection expected to impact compliance or safety as judged by the investigator
•12. Any surgical procedure in the 30 days prior to enrolment and any planned surgery during the trial period
•13. Medical, social, or psychosocial factors expected to impact compliance or safety
•14. 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

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