Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
Public ClinicalTrials.gov record NCT00708435. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00708435
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 216 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2008 (Type not available)
- Primary completion
- Nov 2010 (Actual)
- Completion
- Nov 2010 (Actual)
- Last update posted
- Feb 3, 2014
2008 – 2010
United States locations
- U.S. sites
- 41
- U.S. states
- 19
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site | Birmingham | Alabama | 35248-3280 | — |
| Study Site | Los Angeles | California | 90033 | — |
| Study Site | San Franciso | California | 94115 | — |
| Study Site | Newark | Delaware | 19718 | — |
| Study Site | Orlando | Florida | 32806 | — |
| Study Site | Tampa | Florida | 33606 | — |
| Study Site | Chicago | Illinois | 60612 | — |
| Study Site | Oak Park | Illinois | 60302 | — |
| Study Site | Hazard | Kentucky | 41701 | — |
| Study Site | Baltimore | Maryland | 21201 | — |
| Study Site | Baltimore | Maryland | 21205 | — |
| Study Site | Boston | Massachusetts | 02114 | — |
| Study Site | Worchester | Massachusetts | 01655 | — |
| Study Site | Ann Arbor | Michigan | 48106 | — |
| Study Site | Royal Oak | Michigan | 48073 | — |
| Study Site | Duluth | Minnesota | 55805 | — |
| Study Site | Minneapolis | Minnesota | 55114 | — |
| Study Site | Jackson | Mississippi | 39216 | — |
| Study Site | St Louis | Missouri | 63110 | — |
| Study Site | Albuquerque | New Mexico | 87131 | — |
| Study Site | Albany | New York | 12208 | — |
| Study Site | Johnson City | New York | 13790 | — |
| Study Site | New York | New York | 10003 | — |
| Study Site | New York | New York | 10029 | — |
| Study Site | New York | New York | 10032 | — |
| Study Site | Rochester | New York | 14642 | — |
| Study Site | Staten Island | New York | 10305 | — |
| Study Site | Durham | North Carolina | 27710 | — |
| Study Site | Allentown | Pennsylvania | 18103 | — |
| Study Site | Hershey | Pennsylvania | 17033 | — |
| Study Site | Philadelphia | Pennsylvania | 19107 | — |
| Study Site | Philadelphia | Pennsylvania | 19140 | — |
| Study Site | West Reading | Pennsylvania | 19611 | — |
| Study Site | Austin | Texas | 78701 | — |
| Study Site | El Paso | Texas | 79905 | — |
| Study Site 2 | Houston | Texas | 77030 | — |
| Study Site | Houston | Texas | 77030 | — |
| Study Site | Temple | Texas | 76508 | — |
| Study Site | Salt Lake City | Utah | 84132 | — |
| Study Site | Charlottesville | Virginia | 22908 | — |
| Study Site | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00708435, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2014 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00708435 live on ClinicalTrials.gov.