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Prothrombin Complex Concentrate for Anticoagulant Reversal

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CSL Behring

Status and phase

Completed
Phase 3

Conditions

Acquired Coagulation Factor Deficiency

Treatments

Drug: Prothrombin Complex Concentrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00168077
BE1116_3001

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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