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Beriplex P/N vs plasma for rapid reversal of vitamin K antagonist-induced coagulopathy
2007-007861-19Phase 3Completed
- Sponsor
- CSL Limited
- Start
- Jan 2009
- Modality
- Blood Coagulation Factors → Therapeutic Enzymes → Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, randomised, open-label trial of balfaxar in vitamin K deficiency bleeding (VKDB), coagulopathy and Not applicable (2 arms), sponsored by CSL Limited. Primary endpoints: Hemostatic efficacy and Plasma levels of coagulation factors II, VII, IX, X, protein C and protein S. Started Jan 2009; status: completed.
02
Drugs
balfaxar
03
Conditions
vitamin K deficiency bleeding (VKDB)coagulopathyNot applicable
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