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.
Public ClinicalTrials.gov record NCT02740335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02740335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 208 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 8, 2017 (Actual)
- Primary completion
- Feb 23, 2022 (Actual)
- Completion
- Feb 23, 2022 (Actual)
- Last update posted
- Mar 8, 2023
2017 – 2022
United States locations
- U.S. sites
- 22
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Octapharma Research Site | Aurora | Colorado | 80045 | — |
| Octapharma Research Site | New Haven | Connecticut | 06510 | — |
| Octapharma Research Site | Miami | Florida | 33136 | — |
| Octapharma Research Site | Tampa | Florida | 33606 | — |
| Octapharma Research Site | Iowa City | Iowa | 52242 | — |
| Octapharma Research Site | Boston | Massachusetts | 02114 | — |
| Octapharma Research Site | Rochester | New York | 14642 | — |
| Octapharma Research Site | Durham | North Carolina | 27710 | — |
| Octapharma Research Site | Cleveland | Ohio | 44109 | — |
| Octapharma Research Site | Columbus | Ohio | 43210 | — |
| Octapharma Research Site | Dayton | Ohio | 45409 | — |
| Octapharma Research Site | Fairborn | Ohio | 45324 | — |
| Octapharma Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Octapharma Study Site | Pittsburgh | Pennsylvania | 15213 | — |
| Octapharma Research Site | Pittsburgh | Pennsylvania | 15219 | — |
| Octapharma Research Site | Pittsburgh | Pennsylvania | 15232 | — |
| Octapharma Research Site | Pittsburgh | Pennsylvania | 15237 | — |
| Octapharma Research Site (0115) | Austin | Texas | 78701 | — |
| Octapharma Research Site (0127) | Austin | Texas | 78701 | — |
| Octapharma Research Site | Dallas | Texas | 75390 | — |
| Octapharma Research Site | Round Rock | Texas | 78665 | — |
| Octapharma Research Site | Puyallup | Washington | 98374 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02740335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 8, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02740335 live on ClinicalTrials.gov.