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Clinical trial

An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Coumarin Derivatives in Subjects With Acute Major Bleeding

NCT00708435 is registered in ClinicalTrials.gov with CSL Behring as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Coumarin Derivatives in Subjects With Acute Major Bleeding
Lead sponsor
CSL Behring
Phase
Phase 3
Overall status
Completed
Start date
June 30, 2008
Completion date
November 30, 2010
Enrollment
216 (actual)
Sites
69

Conditions

As the registry lists them; a condition with its own page is linked.

acute major bleeding, blood coagulation disorders