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Showing 1–6 of 6 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Kcentra® Clear all
Recruiting No phase listed Observational

Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

NCT06429787
View directory record Official record
Conditions
Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk
Interventions
Balfaxar, Kcentra
Drug
Lead sponsor
Octapharma
Industry
Eligibility
18 Years and older
Enrollment
3,574 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2032
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 8, 2026, 2:45 PM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy

NCT00708435
View directory record Official record
Conditions
Blood Coagulation Disorders, Acute Major Bleeding
Interventions
Beriplex® P/N (Kcentra), Fresh frozen plasma
Biological
Lead sponsor
CSL Behring
Industry
Eligibility
18 Years and older
Enrollment
216 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
41
States / cities
Birmingham, Alabama • Los Angeles, California • San Franciso, California + 33 more
Source: ClinicalTrials.gov public record
Updated Feb 2, 2014 · Synced Sep 8, 2026, 2:45 PM EDT
Terminated Phase 3 Interventional Results available

Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )

NCT05568888
View directory record Official record
Conditions
Traumatic Injury
Interventions
BE1116, Placebo
Drug
Lead sponsor
CSL Behring
Industry
Eligibility
15 Years and older
Enrollment
1,366 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
90
States / cities
Birmingham, Alabama • Mobile, Alabama • Chandler, Arizona + 79 more
Source: ClinicalTrials.gov public record
Updated Dec 9, 2025 · Synced Sep 8, 2026, 2:45 PM EDT
Completed No phase listed Observational

An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding

NCT02319460
View directory record Official record
Conditions
Hemorrhage
Interventions
Kcentra®, Plasma
Biological
Lead sponsor
CSL Behring
Industry
Eligibility
18 Years and older
Enrollment
2,238 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
1
States / cities
Oakland, California
Source: ClinicalTrials.gov public record
Updated May 25, 2021 · Synced Sep 8, 2026, 2:45 PM EDT
Completed Phase 3 Interventional Results available

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

NCT00803101
View directory record Official record
Conditions
Reversal of Coagulopathy
Interventions
Beriplex® P/N (Kcentra), Fresh frozen plasma
Biological
Lead sponsor
CSL Behring
Industry
Eligibility
18 Years and older
Enrollment
176 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
16
States / cities
Newark, Delaware • Lexington, Kentucky • Boston, Massachusetts + 13 more
Source: ClinicalTrials.gov public record
Updated Apr 5, 2015 · Synced Sep 8, 2026, 2:45 PM EDT
Completed Phase 3 Interventional Results available

Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

NCT02740335
View directory record Official record
Conditions
Significant Bleeding Risk
Interventions
Octaplex, Beriplex P/N (Kcentra)
Drug
Lead sponsor
Octapharma
Industry
Eligibility
18 Years and older
Enrollment
208 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
22
States / cities
Aurora, Colorado • New Haven, Connecticut • Miami, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Mar 7, 2023 · Synced Sep 8, 2026, 2:45 PM EDT