Trial Condition(s):

Venous thrombosis

Oral Rivaroxaban in Children with Venous Thrombosis (EINSTEINJunior)

Bayer Identifier:

14373

ClinicalTrials.gov Identifier:

NCT01684423

EudraCT Number:

2011-004539-30

Study Completed

Trial Purpose

The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.

Inclusion Criteria
- Children aged 6 to < 18 years with documented symptomatic or asymptomatic venous thrombosis treated for at least 2 months or, in case of catheter related thrombosis, treated for at least 6 weeks with LMWH (low molecular weight heparin), , fondaparinux and/or VKA (vitamin K antagonist). 
 - Informed consent provided and, if applicable, child assent provided
Exclusion Criteria
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
 - Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
 - Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
 - An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 
 - Hepatic disease which is associated with 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 10^9/L
 - 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), i.e. 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, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine

Trial Summary

Enrollment Goal
64
Trial Dates
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Phase
2
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

Lübeck, Germany, 23538

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60590

Status
Terminated
 
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Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43205-2696

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Terminated
 
Locations

Investigative Site

Los Angeles, United States, 90027-6089

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75019

Status
Terminated
 
Locations

Investigative Site

TOULOUSE Cedex 9, France, 31059

Status
Terminated
 
Locations

Investigative Site

Genova, Italy, 16147

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10126

Status
Completed
 
Locations

Investigative Site

Bari, Italy, 70124

Status
Completed
 
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Investigative Site

AMSTERDAM, Netherlands

Status
Completed
 
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Investigative Site

UTRECHT, Netherlands, 3584 CX

Status
Terminated
 
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Investigative Site

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
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Investigative Site

AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
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Investigative Site

ROTTERDAM, Netherlands, 3015 GJ

Status
Terminated
 
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Investigative Site

Ramat Gan, Israel, 5262000

Status
Terminated
 
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Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
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Investigative Site

Petach Tikva, Israel, 4920235

Status
Completed
 
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Investigative Site

Parkville, Australia, 3052

Status
Completed
 
Locations

Investigative Site

South Brisbane, Australia, 4101

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
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Investigative Site

Graz, Austria, 8036

Status
Completed
 
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Investigative Site

Zürich, Switzerland, 8032

Status
Completed
 
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Investigative Site

Basel, Switzerland, 4056

Status
Terminated
 
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Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
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Investigative Site

St. Gallen, Switzerland, 9006

Status
Terminated
 
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Investigative Site

Toronto, Canada, M5G 1X8

Status
Terminated
 
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Investigative Site

Hamilton, Canada, L8N 3Z5

Status
Terminated
 
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Investigative Site

Westmead, Australia, 2145

Status
Terminated
 
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Investigative Site

Ottawa, Canada, K1H 8L1

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 
Locations

Investigative Site

Richmond, United States, 23298

Status
Terminated
 
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Investigative Site

Quebec, Canada, G1V 4G2

Status
Terminated
 
Locations

Investigative Site

Chicago, United States, 60611

Status
Terminated
 
Locations

Investigative Site

Cleveland, United States, 44106-2602

Status
Terminated
 
Locations

Investigative Site

Indianapolis, United States, 46202

Status
Completed
 
Locations

Investigative Site

Orange, United States, 92868-3974

Status
Terminated
 
Locations

Investigative Site

PARIS, France, 75015

Status
Completed
 
Locations

Investigative Site

Montpellier Cedex, France, 34295

Status
Completed
 
Locations

Investigative Site

BORDEAUX cedex, France, 33076

Status
Terminated
 
Locations

Investigative Site

Beer Sheva, Israel, 8410101

Status
Terminated
 
Locations

Investigative Site

Minneapolis, United States, 55404

Status
Completed
 
Locations

Investigative Site

Erlangen, Germany, 91054

Status
Terminated
 
Locations

Investigative Site

Detroit, United States, 48201-2196

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 2B7

Status
Terminated
 
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Investigative Site

Little Rock, United States, 72202-3500

Status
Terminated
 
Locations

Investigative Site

New Hyde Park, United States, 11040

Status
Completed
 
Locations

Investigative Site

Linz, Austria, 4020

Status
Terminated
 
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Investigative Site

Haifa, Israel, 3109601

Status
Terminated
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
Locations

Investigative Site

Freiburg, Germany, 79106

Status
Terminated
 
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Investigative Site

Luzern, Switzerland, 6000

Status
Terminated
 
Locations

Investigative Site

RENNES CEDEX, France, 35033

Status
Terminated
 
Locations

Investigative Site

NANTES Cedex 1, France, 44093

Status
Terminated
 
Locations

Investigative Site

Pavia, Italy, 27100

Status
Terminated
 

Trial Design