# 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

> **NCT00803101** · PHASE3 · COMPLETED · sponsor: **CSL Behring** · enrollment: 176 (actual)

## Conditions studied

- Reversal of Coagulopathy

## Interventions

- **BIOLOGICAL:** Beriplex® P/N (Kcentra)
- **BIOLOGICAL:** Fresh frozen plasma

## Key facts

- **NCT ID:** NCT00803101
- **Lead sponsor:** CSL Behring
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-02
- **Primary completion:** 2012-11
- **Final completion:** 2013-02
- **Target enrollment:** 176 (ACTUAL)
- **Last updated:** 2015-04-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00803101

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00803101, "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". Retrieved via AI Analytics 2026-07-25 from https://api.ai-analytics.org/clinical/NCT00803101. Licensed CC0.

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