EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

PHASE3CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

November 13, 2014

Primary Completion Date

January 30, 2019

Study Completion Date

January 30, 2019

Conditions
Venous Thromboembolism
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension

DRUG

Standard of Care

"LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy.~dose : as per standard of care"

Trial Locations (109)

12

Crumlin

1090

Vienna

1097

Budapest

1200

Bruxelles - Brussel

2650

Edegem

3000

Leuven

3010

Bern

3052

Parkville

4000

San Miguel de Tucumán

4020

Linz

4101

South Brisbane

6000

Lucerne

6020

Innsbruck

8032

Zurich

8036

Graz

10126

Turin

13353

Berlin

15006

A Coruña

19104

Philadelphia

20122

Milan

20520

Turku

27710

Durham

30322

Atlanta

31059

Toulouse

32207

Jacksonville

32504

Pensacola

32610

Gainesville

33155

Miami

33701

St. Petersburg

34059

Montpellier

34093

Istanbul

35128

Padua

42080

Konya

46202

Indianapolis

48912

Lansing

60611

Chicago

75015

Paris

75235

Dallas

76104

Fort Worth

77030

Houston

85016

Phoenix

90095

Los Angeles

91054

Erlangen

92123

San Diego

100034

Beijing

100045

Beijing

117997

Moscow

119049

Moscow

119228

Singapore

197022

Saint Petersburg

197110

Saint Petersburg

350013

Krasnodar

400138

Volgograd

420138

Kazan'

603136

Nizhny Novgorod

620028

Yekaterinburg

650002

Kemerovo

1834111

Afula

4920235

Petah Tikva

5262000

Ramat Gan

9112001

Jerusalem

72202-3500

Little Rock

90027-6089

Los Angeles

64108-9898

Kansas City

45229-3039

Cincinnati

44106-2602

Cleveland

43205-2696

Columbus

13083-970

Campinas

01227-200

São Paulo

04023-061

São Paulo

05403-000

São Paulo

T3B 6A8

Calgary

T6G 2B7

Edmonton

L8N 3Z5

Hamilton

K1H 8L1

Ottawa

M5G 1X8

Toronto

H4A 3J1

Montreal

Unknown

Hangzhou

Shanghai

Hong Kong

Guadalajara

01307

Dresden

06120

Halle

474-8710

Ōbu

399-8288

Azumino

113-8655

Bunkyo-ku

06720

Mexico City

1105 AZ

Amsterdam

9713 GZ

Groningen

6525 GA

Nijmegen

3015 CE

Rotterdam

3584 CX

Utrecht

2795-53

Carnaxide

229 899

Singapore

833 41

Bratislava

08950

Esplugues de Llobregat

08035

Barcelona

171 64

Solna

01130

Adana

NE1 4LP

Newcastle upon Tyne

B4 6NH

Birmingham

LS1 3EX

Leeds

CF14 4XW

Cardiff

EH9 1LF

Edinburgh

G51 4TF

Glasgow

SW3 6NP

London

M13 9WL

Manchester

OX3 9DU

Oxford

S10 2TH

Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY