Trials / Completed
CompletedNCT00708435
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Coumarin Derivatives in Subjects With Acute Major Bleeding
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Beriplex® P/N (Kcentra) | Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight |
| BIOLOGICAL | Fresh frozen plasma | Intravenous Infusion, dosage depending on baseline INR and body weight |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2008-07-02
- Last updated
- 2014-02-03
- Results posted
- 2013-08-13
Locations
69 sites across 6 countries: United States, Belarus, Bulgaria, Romania, Russia, Ukraine
Source: ClinicalTrials.gov record NCT00708435. Inclusion in this directory is not an endorsement.