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NCT00803101 · ClinicalTrials.gov registry record · Phase 3
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
A Phase 3 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 176
- Enrollment target
NCT00803101: Completed Phase 3 study, sponsored by CSL Behring.
NCT00803101 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 176 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00803101, a Phase 3 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 176 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.
Primary Outcome
Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none".
Interventions
- BIOLOGICAL Fresh frozen plasma
- BIOLOGICAL Beriplex® P/N (Kcentra)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT00803101 record still lists
NCT00803101 is an interventional study that assigns participants to a tested intervention. The registered 176 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 (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Fresh frozen plasma is the first listed.
NCT00803101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00803101 about?
NCT00803101 is a clinical study titled "An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure". The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergen...
What is the current status of trial NCT00803101?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2009-02. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00803101?
The interventions under investigation include: Fresh frozen plasma (BIOLOGICAL), Beriplex® P/N (Kcentra) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00803101?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00803101's enrollment target sits among peer trials
176 1438th of 2000 higher than 561 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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