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NCT02740335 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
NCT02740335: Completed Phase 3 study, sponsored by Octapharma.
NCT02740335 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 208 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02740335, a Phase 3 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
Study 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).
Primary Outcome
Hemostatic Efficacy rated by the Independent Endpoint Adjudication Committee based on a 1 to 4 point hemostatic efficacy scale, taking into account blood loss and transfusion requirements in the context of the surgery. Hemostatic efficacy was assessed based on objective criteria in the categories 'excellent', 'good', 'moderate', or 'none'. Ratings of 'excellent' and 'good' were considered as 'effective' hemostasis, while ratings of 'moderate' and 'none' were considered as 'ineffective' hemostasi
Interventions
- DRUG Octaplex
- DRUG Beriplex P/N (Kcentra)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2022-02-23 |
| Phase | Phase 3 |
What the finished NCT02740335 record still lists
NCT02740335 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Octaplex is the first listed.
NCT02740335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02740335 about?
NCT02740335 is a clinical study titled "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.". 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).
What is the current status of trial NCT02740335?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2017-06-08. Estimated completion is 2022-02-23.
What interventions are being tested in trial NCT02740335?
The interventions under investigation include: Octaplex (DRUG), Beriplex P/N (Kcentra) (DRUG).
Who is sponsoring clinical trial NCT02740335?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02740335's enrollment target sits among peer trials
208 1345th of 2000 higher than 655 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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