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NCT00708435 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Blood Coagulation Disorders and Acute Major Bleeding, sponsored by CSL Behring.

Completed
Registry status
Phase 3
Development phase
216
Enrollment target
20
Study locations

NCT00708435 is a Phase 3 study of Blood Coagulation Disorders and Acute Major Bleeding that has completed, run by CSL Behring. The registered enrollment target is 216 participants, roughly in line with the 227-participant average among 6 other Blood Coagulation Disorders trials with a reported enrollment target. The trial reports 20 study locations across 13 states.

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The verdict

NCT00708435, a Phase 3 study of Blood Coagulation Disorders and Acute Major Bleeding, has completed, sponsored by CSL Behring.

COMPLETED
Registry status
Phase 3
Development phase
216 participants
Enrollment target
20
Study locations

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 coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.

Conditions Studied

Blood Coagulation Disorders Acute Major Bleeding

Interventions

  • BIOLOGICAL Fresh frozen plasma
  • BIOLOGICAL Beriplex® P/N (Kcentra)

Study Locations (20)

California

  • Study Site - Los Angeles
  • Study Site - San Franciso

Florida

  • Study Site - Orlando
  • Study Site - Tampa

Illinois

  • Study Site - Chicago
  • Study Site - Oak Park

Maryland

  • Study Site - Baltimore
  • Study Site - Baltimore

Massachusetts

  • Study Site - Boston
  • Study Site - Worchester

Michigan

  • Study Site - Ann Arbor
  • Study Site - Royal Oak

Minnesota

  • Study Site - Duluth
  • Study Site - Minneapolis

Alabama

  • Study Site - Birmingham

Trial Details

FieldValue
Enrollment Target 216 participants
Start Date 2008-06
Est. Completion 2010-11
Phase Phase 3

Sponsor

CSL Behring

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00708435

The ClinicalTrials.gov registry entry for NCT00708435 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 227-participant average among 6 other Blood Coagulation Disorders trials with a reported enrollment target. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Blood Coagulation Disorders appearing as the primary indexed condition, and to 2 interventions - of which Fresh frozen plasma is the first listed.

NCT00708435 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT00708435 about?

NCT00708435 is a clinical study titled "Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy". 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...

What is the current status of trial NCT00708435?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 2008-06. Estimated completion is 2010-11.

What conditions does trial NCT00708435 study?

This clinical trial studies the following conditions: Blood Coagulation Disorders, Acute Major Bleeding.

What interventions are being tested in trial NCT00708435?

The interventions under investigation include: Fresh frozen plasma (BIOLOGICAL), Beriplex® P/N (Kcentra) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00708435?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00708435 being conducted?

This trial has 20 study locations across Alabama, California, Delaware, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.