Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
Completed · Phase 3
Conditions studied: Congenital Bleeding Disorder, Congenital FXIII Deficiency
In brief
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 bleeding episodes in children aged between 1 and 6 years with congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4, NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on when recombinant factor XIII will be commercially available in subject's respective country for use in children of 1-6 years of age.
Key facts
- Study ID
- NCT01253811
- Run by
- Novo Nordisk A/S
- People needed
- 6
- Starts
- 2011-01-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-06-24
Who can join
Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Completed participation in trial F13CD-3760 (NCT01230021)
You may not qualify if…
- 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
Where it is running
- Novo Nordisk Clinical Trial Call Center — Boston, Massachusetts, United States
- Novo Nordisk Clinical Trial Call Center — Columbus, Ohio, United States
- Study site — Petah Tikva, Israel
- Study site — Leicester, United Kingdom
Full record on ClinicalTrials.gov
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