Prothrombin Complex Concentrate for Anticoagulant Reversal

Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168077

Enrollment

Registered

2005-09-14

Start date

2005-09-30

Completion date

2006-11-30

Last updated

2011-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Coagulation Factor Deficiency

Keywords

Prothrombin Complex Concentrate, Anticoagulant reversal

Brief summary

Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.

Interventions

DRUGProthrombin Complex Concentrate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery * INR \> 2 at baseline Key

Exclusion criteria

* Acute thromboembolic event * Treatment with any other investigational drug in the last 30 days before study entry * Less than 2 weeks of stable oral anticoagulation

Design outcomes

Primary

Measure	Time frame
Rapid reversal of anticoagulatory effect	—

Secondary

Measure	Time frame
Clinical efficacy assessment (hemostatic effect)	—
Increase of coagulation factors	—

Countries

Austria, Germany, Hungary, Israel, Lithuania, Netherlands, Poland, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026