A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)

PHASE3CompletedINTERVENTIONAL
Enrollment

479

Participants

Timeline

Start Date

April 10, 2015

Primary Completion Date

September 24, 2020

Study Completion Date

September 24, 2020

Conditions
Bleeding
Interventions
BIOLOGICAL

Andexanet

There were 2 possible dosing regimens: Low dose = 400 milligram (mg) bolus plus 4 mg/minute continuous infusion for 120 minutes; High dose = 800 mg bolus plus 8 mg/minute continuous infusion for 120 minutes.

Trial Locations (87)

Unknown

Clinical Study Site, Long Beach

Clinical Study Site, Los Angeles

Clinical Study Site, Orange

Clinical Study Site, Fort Lauderdale

Clinical Study Site, Jacksonville

Clinical Study Site, Sarasota

Clinical Study Site, Tampa

Clinical Study Site, Annapolis

Clinical Study Site, Boston

Clinical Study Site, Detroit

Clinical Study Site, Royal Oak

Clinical Study Site, Troy

Clinical Study Site, St Louis

Clinical Study Site, Rochester

Clinical Study Site, Asheville

Clinical Study Site, Chapel Hill

Clinical Study Site, Raleigh

Clinical Study Site, Cincinnati

Clinical Study Site, Cleveland

Clinical Study Site, Pittsburgh

Clinical Study Site, Austin

Clinical Study Site, Fort Worth

Clinical Study Site, Huntington

Clinical Study Site, Brussels

Clinical Study Site, Genk

Clinical Study Site, Leuven

Clinical Study Site, Hamilton

Clinical Study Site, Montreal

Clinical Study Site, Clermont-Ferrand

Clinical Study Site, Grenoble

Clinical Study Site, Limoges

Clinical Study Site, Lyon

Clinical Study Site, Poitiers

Clinical Study Site, Altenburg

Clinical Study Site, Augsburg

Clinical Study Site, Berlin

Clinical Study Site, Bremen

Clinical Study Site, Celle

Clinical Study Site, Chemnitz

Clinical Study Site, Coburg

Clinical Study Site, Detmold

Clinical Study Site, Dresden

Clinical Study Site, Essen

Clinical Study Site, Göttingen

Clinical Study Site, Greifswald

Clinical Study Site, Halle

Clinical Study Site, Hamburg

Clinical Study Site, Hanover

Clinical Study Site, Heidelberg

Clinical Study Site, Hessen

Clinical Study Site, Jena

Clinical Study Site, Konstanz

Clinical Study Site, Leipzig

Clinical Study Site, Ludwigshafen

Clinical Study Site, Lübeck

Clinical Study Site, Mainz

Clinical Study Site, Minden

Clinical Study Site, Munich

Clinical Study Site, Münster

Clinical Study Site, Osnabrück

Clinical Study Site, Regensburg

Clinical Study Site, Sande

Clinical Study Site, Trier

Clinical Study Site, Tübingen

Clinical Study Site, Ulm

Clinical Study Site, Würzburg

Clinical Study Site, Fukuoka

Clinical Study Site, Gunma

Clinical Study Site, Hiroshima

Clinical Study Site, Ibaraki

Clinical Study Site, Izumisano

Clinical Study Site, Kobe

Clinical Study Site, Kumamoto

Clinical Study Site, Nagoya

Clinical Study Site, Sendai

Clinical Study Site, Shiwa-gun

Clinical Study Site, Suita

Clinical Study Site, Tokyo

Clinical Study Site, Yamaguchi

Clinical Study Site, Yokosuka

Clinical Study Site, Amsterdam

Clinical Study Site, Barcelona

Clinical Study Site, Cáceres

Clinical Study Site, Madrid

Clinical Study Site, Cardiff

Clinical Study Site, London

Clinical Study Site, Stoke-on-Trent

All Listed Sponsors
collaborator

Portola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals)

INDUSTRY

collaborator

Population Health Research Institute

OTHER

lead

Alexion Pharmaceuticals, Inc.

INDUSTRY