Trial Condition(s):

Venous Thromboembolism

EINSTEIN Junior Phase II: oral rivaroxaban in young children with venous thrombosis (EINSTEINJr)

Bayer Identifier:

14374

ClinicalTrials.gov Identifier:

NCT02309411

EudraCT Number:

2014-000566-22

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. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.

Inclusion Criteria
- Children aged 6 months  to < 6 years who have been treated for at least 2 months or, in case of catheter related thrombosis, for at least 6 weeks with LMWH (low molecular weight heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic or asymptomatic venous thrombosis  - Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days  prior to randomization
 - Informed consent 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 m^2  
 - 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 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
 - Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental  treatment 
 - Inability to cooperate with the study procedures 
 - Previous randomization to this study 
 - Participation in a study with an investigational drug or medical device within 30 days prior to randomization

Trial Summary

Enrollment Goal
46
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

Wien, Austria, 1090

Status
Terminated
 
Locations

Investigative Site

Chicago, United States, 60611

Status
Completed
 
Locations

Children's Healthcare of Atlanta

Atlanta, United States, 30322

Status
Completed
 
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Investigative Site

Gainesville, United States, 32610

Status
Completed
 
Locations

Investigative Site

Indianapolis, United States, 46202

Status
Completed
 
Locations

Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
Locations

Investigative Site

Parkville, Australia, 3052

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197022

Status
Completed
 
Locations

Investigative Site

Nizhny Novgorod, Russia, 603136

Status
Completed
 
Locations

Investigative Site

Newcastle Upon Tyne, United Kingdom, NE1 4LP

Status
Completed
 
Locations

Investigative Site

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 01227-200

Status
Completed
 
Locations

Investigative Site

Birmingham, United Kingdom, B4 6NH

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10126

Status
Completed
 
Locations

Investigative Site

Cardiff, United Kingdom, CF14 4XW

Status
Completed
 
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Investigative Site

Valencia, Spain, 46026

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
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Investigative Site

Pensacola, United States, 32504

Status
Completed
 
Locations

Investigative Site

Olsztyn, Poland, 10-561

Status
Terminated
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 1X8

Status
Completed
 
Locations

Investigative Site

Setagaya, Japan, 157-8535

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 117997

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1097

Status
Completed
 
Locations

Investigative Site

Gdansk, Poland, 80-952

Status
Terminated
 

Trial Design