At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 208 enrolled

Drug / intervention

Octaplex +1 moredrug

Likely dose

Octaplex 0.12 mLfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02740335

NCT02740335Phase 3Completed

Compare CT.gov

A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate (4F-PCC), Compared to the 4F-PCC Beriplex® P/N (Kcentra), for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

Octapharma·interventional·Posted Apr 15, 2016·Updated Mar 8, 2023

In Brief

A Phase 3 clinical trial evaluating Octaplex and Beriplex P/N (Kcentra) for Significant Bleeding Risk. Completed, enrolled 208 participants across 86 sites in 11 countries.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSignificant Bleeding Risk

CountriesBelarus, Bulgaria, Georgia, Germany, Moldova, Poland, Romania, Russia, Spain, Ukraine, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2017201820192020202120222023202420252026

First PostedApr 2016

Enrollment StartJun 2017

Primary CompletionFeb 2022

TodayJul 2026

First PostedApr 15, 2016

Enrollment StartJun 8, 2017

Primary CompletionFeb 23, 2022

TodayJul 2, 2026

Enrollment to primary: 4.7 yearsPosted 10.2 years ago

Interventions

Octaplexdrug

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).

Beriplex P/N (Kcentra)drug

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).