# Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy

> **NCT00708435** · PHASE3 · COMPLETED · sponsor: **CSL Behring** · enrollment: 216 (actual)

## Conditions studied

- Blood Coagulation Disorders
- Acute Major Bleeding

## Interventions

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

## Key facts

- **NCT ID:** NCT00708435
- **Lead sponsor:** CSL Behring
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2008-06
- **Primary completion:** 2010-11
- **Final completion:** 2010-11
- **Target enrollment:** 216 (ACTUAL)
- **Last updated:** 2014-02-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00708435

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00708435, "Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy". Retrieved via AI Analytics 2026-07-26 from https://api.ai-analytics.org/clinical/NCT00708435. Licensed CC0.

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