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

PHASE3CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Blood Coagulation DisordersAcute Major Bleeding
Interventions
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

Trial Locations (69)

10003

Study Site, New York

10029

Study Site, New York

10032

Study Site, New York

10305

Study Site, Staten Island

12208

Study Site, Albany

13790

Study Site, Johnson City

14642

Study Site, Rochester

17033

Study Site, Hershey

18103

Study Site, Allentown

19107

Study Site, Philadelphia

19140

Study Site, Philadelphia

19611

Study Site, West Reading

19718

Study Site, Newark

21201

Study Site, Baltimore

21205

Study Site, Baltimore

22908

Study Site, Charlottesville

23298

Study Site, Richmond

27710

Study Site, Durham

32806

Study Site, Orlando

33606

Study Site, Tampa

39216

Study Site, Jackson

41701

Study Site, Hazard

48073

Study Site, Royal Oak

48106

Study Site, Ann Arbor

55114

Study Site, Minneapolis

55805

Study Site, Duluth

60302

Study Site, Oak Park

60612

Study Site, Chicago

63110

Study Site, St Louis

76508

Study Site, Temple

77030

Study Site 2, Houston

Study Site, Houston

78701

Study Site, Austin

79905

Study Site, El Paso

84132

Study Site, Salt Lake City

87131

Study Site, Albuquerque

90033

Study Site, Los Angeles

94115

Study Site, San Franciso

650002

Study Site, Kemerovo

35248-3280

Study Site, Birmingham

02114

Study Site, Boston

01655

Study Site, Worchester

Unknown

Study Site 1, Minsk

Study Site 2, Minsk

Study Site, Pleven

Study Site, Plovdiv

Study Site, Rousse

Study Site 1, Sofia

Study Site 2, Sofia

Study Site 3, Sofia

Study Site 4, Sofia

Study Site, Brasov

Study Site 1, Bucharest

Study Site 2, Bucharest

Study Site 3, Bucharest

Study Site, Cluj-Napoca

Study Site, Timișoara

Study Site, Arkhangelsk

Study Site 1, Barnaul

Study Site 2, Barnaul

Study Site, Kazan'

Study Site 1, Moscow

Study Site 2, Moscow

Study Site 1, Nizhny Novgorod

Study Site 2, Nizhny Novgorod

Study Site 1, Saint Petersburg

Study Site 2, Saint Petersburg

Study Site, Kharkiv

Study Site, Vinnytsa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY

NCT00708435 - Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy | Biotech Hunter | Biotech Hunter