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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2023-03-08

Study results available
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Summary

To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).

Conditions

  • Significant Bleeding Risk

Interventions

DRUG

Octaplex

OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).

DRUG

Beriplex P/N (Kcentra)

Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Wolfgang Frenzel · International Medical Monitor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2022-02-23
Completion
2022-02-23
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Bulgaria
  • Georgia
  • Germany
  • Moldova
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02740335 on ClinicalTrials.gov