A Phase 1 interventional study of catridecacog and recombinant factor XIII in Congenital Bleeding Disorder, Congenital FXIII Deficiency and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-21.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 51 is close to the median of 52 across 252 interventional studies indexed under Hemostatic Disorders.
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Exclusion Criteria:
Drug: catridecacog
Drug: recombinant factor XIII
Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv.
Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv.
Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay
Time frame: after 4 weeks of treatment
Number of adverse events (serious and non-serious)
Time frame: over 8 weeks of treatment
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S