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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 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 208 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02740335
The ClinicalTrials.gov registry entry for NCT02740335 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Octaplex is the first listed.
NCT02740335 reports 0 study locations.
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.
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