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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 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 176 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00803101
The ClinicalTrials.gov registry entry for NCT00803101 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fresh frozen plasma is the first listed.
NCT00803101 reports 0 study locations.
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.
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