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An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
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Trial · NCT00803101

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

1 to 20 of 64

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OutcomeGroupCategoryValueSpreadUnits
Percentage of Participants Achieving Hemostatic Efficacy During SurgeryBeriplex® P/N89.795% Confidence Interval 83.3 to 96.1percentage of participants
Percentage of Participants Achieving Hemostatic Efficacy During SurgeryFresh Frozen Plasma75.395% Confidence Interval 65.9 to 84.7percentage of participants
Percentage of Participants Who Had a Rapid Decrease of the INRBeriplex® P/N55.295% Confidence Interval 44.7 to 65.6percentage of participants
Percentage of Participants Who Had a Rapid Decrease of the INRFresh Frozen Plasma9.995% Confidence Interval 3.4 to 16.4percentage of participants
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor II, pre-infusion (n = 85; 79)32.0Standard Deviation 19.93percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor II, pre-infusion (n = 85; 79)34.8Standard Deviation 26.19percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor II, 0.5 h after infusion start (n = 71; 73)84.5Standard Deviation 20.92percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor II, 0.5 h after infusion start (n = 71; 73)42.5Standard Deviation 25.71percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor II, 24 h after infusion start (n = 81; 74)81.4Standard Deviation 24.83percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor II, 24 h after infusion start (n = 81; 74)65.6Standard Deviation 23.68percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor VII, pre-infusion start (n = 85; 79)36.8Standard Deviation 59.27percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor VII, pre-infusion start (n = 85; 79)31.1Standard Deviation 25.16percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor VII, 0.5h after infusion start (n = 71; 73)60.1Standard Deviation 44.91percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor VII, 0.5h after infusion start (n = 71; 73)41.6Standard Deviation 42.90percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor VII, 24 h after infusion start (n = 81; 74)85.5Standard Deviation 59.76percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor VII, 24 h after infusion start (n = 81; 74)83.7Standard Deviation 58.90percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor IX, pre-infusion (n = 85; 79)48.1Standard Deviation 25.62percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor IX, pre-infusion (n = 85; 79)55.8Standard Deviation 30.50percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor IX, 0.5 h after infusion start (n = 71; 73)71.6Standard Deviation 25.38percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor IX, 0.5 h after infusion start (n = 71; 73)56.2Standard Deviation 23.12percentage of normal

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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