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 (BE1116_3003)
|ClinicalTrials.gov Identifier: NCT00803101|
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : February 25, 2014
Last Update Posted : April 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Reversal of Coagulopathy||Biological: Beriplex® P/N (Kcentra) Biological: Fresh frozen plasma||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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 Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||February 2013|
|Experimental: Beriplex® P/N||
Biological: Beriplex® P/N (Kcentra)
Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
Other Name: Kcentra
|Active Comparator: Fresh frozen plasma||
Biological: Fresh frozen plasma
Intravenous infusion, dosage depending on baseline INR and body weight
- Percentage of Participants Achieving Hemostatic Efficacy During Surgery [ Time Frame: From the start of infusion until the end of surgery ]Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none".
- Percentage of Participants Who Had a Rapid Decrease of the INR [ Time Frame: 30 minutes after the end of infusion ]A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.
- Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S [ Time Frame: From pre-infusion until 24 h after the start of infusion ]Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.
- Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood [ Time Frame: From the start of surgery until 24 h after the start of surgery ]The total units of transfused PRBCs or whole blood
- Percentage of Participants With INR Correction at Various Times After the Start of Infusion [ Time Frame: From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion ]The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.
- Percentage of Participants Who Received Red Blood Cells [ Time Frame: From the start of surgery until 24 h after the start of surgery ]Red blood cells were PRBCs and whole blood
- Overall Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs ]Number of participants with TEAEs. TEAEs were defined as adverse events that developed or worsened following exposure to investigational medicinal product. Treatment-related TEAEs were events whose relationship to study treatment was related, probably related, or possibly related in the opinion of the investigator. Treatment emergent adverse events with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent serious adverse events (SAEs).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803101
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|Study Director:||Program Director, Clinical R&D||CSL Behring|