Trial Condition(s):

Venous Thromboembolism

EINSTEIN Junior: oral rivaroxaban in children with venous thrombosis (EINSTEIN Jr)

Bayer Identifier:

14372

ClinicalTrials.gov Identifier:

NCT02234843

EudraCT Number:

2014-000565-47

Study Completed

Trial Purpose

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

Inclusion Criteria
- Children aged birth to < 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low molecular weight heparin) or fondaparinux and require anticoagulant therapy for at least 90 days. However, children aged birth to < 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days.
- For children younger than 6 months: 
-- Gestational age at birth of at least 37 weeks.
-- Oral feeding/nasogastric/gastric feeding for at least 10 days.
-- Body weight ≥2600 g
Exclusion Criteria
- Active bleeding or bleeding risk contraindicating anticoagulant therapy
- An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m*2 (in children younger than 1 year,  serum creatinine results above 97.5th percentile excludes participation)  
- Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
-  Platelet count < 50 x 109/L
-  Sustained uncontrolled hypertension defined as > 95th age percentile   
-  Life expectancy < 3 months
- Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
- Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
- Childbearing potential without proper contraceptive measures, pregnancy or breast feeding

Trial Summary

Enrollment Goal
500
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Little Rock, United States, 72202-3500

Status
Completed
 
Locations

Investigative Site

Los Angeles, United States, 90095

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60611

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43205-2696

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
Locations

Investigative Site

Los Angeles, United States, 90027-6089

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
Locations

Investigative Site

Luzern, Switzerland, 6000

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197022

Status
Completed
 
Locations

Investigative Site

Sankt-Peterburg, Russia, 197110

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 119049

Status
Completed
 
Locations

Investigative Site

Nizhny Novgorod, Russia, 603136

Status
Completed
 
Locations

Investigative Site

Krasnodar, Russia, 350013

Status
Completed
 
Locations

Investigative Site

Yekaterinburg, Russia, 620028

Status
Completed
 
Locations

Investigative Site

Volgograd, Russia, 400138

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117997

Status
Completed
 
Locations

Investigative Site

Guadalajara, Mexico

Status
Completed
 
Locations

Investigative Site

Durham, United States, 27710

Status
Terminated
 
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Investigative Site

Gainesville, United States, 32610

Status
Completed
 
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Investigative Site

Kansas City, United States, 64108-9898

Status
Completed
 
Locations

Investigative Site

Indianapolis, United States, 46202

Status
Completed
 
Locations

Investigative Site

Fort Worth, United States, 76104

Status
Completed
 
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Investigative Site

Cleveland, United States, 44106-2602

Status
Completed
 
Locations

Investigative Site

St. Petersburg, United States, 33701

Status
Completed
 
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Investigative Site

Atlanta, United States, 30322

Status
Completed
 
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Investigative Site

Miami, United States, 33155

Status
Completed
 
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Investigative Site

Lansing, United States, 48912

Status
Completed
 
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Investigative Site

Newcastle Upon Tyne, United Kingdom, NE1 4LP

Status
Completed
 
Locations

Investigative Site

Glasgow, United Kingdom, G51 4TF

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Investigative Site

UTRECHT, Netherlands, 3584 CX

Status
Completed
 
Locations

Investigative Site

GRONINGEN, Netherlands, 9713 GZ

Status
Completed
 
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Investigative Site

ROTTERDAM, Netherlands, 3015 CE

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 04023-061

Status
Completed
 
Locations

Investigative Site

Campinas, Brazil, 13083-970

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 01227-200

Status
Completed
 
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Investigative Site

Birmingham, United Kingdom, B4 6NH

Status
Completed
 
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Investigative Site

Manchester, United Kingdom, M13 9WL

Status
Completed
 
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Investigative Site

Cardiff, United Kingdom, CF14 4XW

Status
Completed
 
Locations

Investigative Site

Sheffield, United Kingdom, S10 2TH

Status
Completed
 
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Investigative Site

Esplugues de LLobregat, Spain, 08950

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
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Investigative Site

A Coruña, Spain, 15006

Status
Completed
 
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Investigative Site

Padova, Italy, 35128

Status
Completed
 
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Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10126

Status
Completed
 
Locations

Investigative Site

Parkville, Australia, 3052

Status
Completed
 
Locations

Investigative Site

MONTPELLIER, France, 34059

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75015

Status
Completed
 
Locations

Investigative Site

TOULOUSE Cedex 9, France, 31059

Status
Completed
 
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Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 
Locations

Investigative Site

Halle, Germany, 06120

Status
Completed
 
Locations

Investigative Site

Erlangen, Germany, 91054

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Linz, Austria, 4020

Status
Completed
 
Locations

Investigative Site

Cincinnati, United States, 45229-3039

Status
Completed
 
Locations

Investigative Site

Phoenix, United States, 85016

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92123

Status
Completed
 
Locations

Investigative Site

Jacksonville, United States, 32207

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Investigative Site

Petach Tikva, Israel, 4920235

Status
Completed
 
Locations

Investigative Site

Crumlin, Ireland, 12

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8N 3Z5

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 1X8

Status
Completed
 
Locations

Investigative Site

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

Investigative Site

Afula, Israel, 1834111

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1H 8L1

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T3B 6A8

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1097

Status
Completed
 
Locations

Investigative Site

Dallas, United States, 75235

Status
Completed
 
Locations

Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Turku, Finland, 20520

Status
Completed
 
Locations

Investigative Site

Leeds, United Kingdom, LS1 3EX

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H4A 3J1

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 05403-000

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100045

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100034

Status
Completed
 
Locations

Investigative Site

Shanghai, China

Status
Completed
 
Locations

Investigative Site

Hangzhou, China

Status
Completed
 
Locations

Investigative Site

Pensacola, United States, 32504

Status
Completed
 
Locations

Investigative Site

Solna, Sweden, 171 64

Status
Completed
 
Locations

Investigative Site

Ciudad de México, Mexico, 06720

Status
Active, not recruiting
 
Locations

Investigative Site

South Brisbane, Australia, 4101

Status
Completed
 
Locations

Investigative Site

Obu, Japan, 474-8710

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Azumino, Japan, 399-8288

Status
Completed
 
Locations

Investigative Site

Edinburgh, United Kingdom, EH9 1LF

Status
Completed
 
Locations

Investigative Site

Kemerovo, Russia, 650002

Status
Completed
 
Locations

Investigative Site

Kazan, Russia, 420138

Status
Completed
 
Locations

Investigative Site

San Miguel de Tucumán, Argentina, 4000

Status
Completed
 
Locations

Investigative Site

Konya, Turkey, 42080

Status
Completed
 
Locations

Investigative Site

Istanbul, Turkey, 34093

Status
Completed
 
Locations

Investigative Site

Adana, Turkey, 01130

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 833 41

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 2B7

Status
Completed
 
Locations

Investigative Site

Oxford, United Kingdom, OX3 9DU

Status
Completed
 
Locations

Investigative Site

Carnaxide, Portugal, 2795-53

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 119228

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 229 899

Status
Completed
 
Locations

Investigative Site

Zürich, Switzerland, 8032

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SW3 6NP

Status
Completed
 

Trial Design