Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Oral Rivaroxaban in Children With Venous Thrombosis (EINSTEINJunior)

This study has been completed.
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 11, 2012
Last updated: October 13, 2016
Last verified: October 2016
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.

Condition Intervention Phase
Venous Thrombosis
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Composite number of major and clinically relevant non major bleeding events after 31 days [ Time Frame: After 31 days ]
  • Composite number of major and clinically relevant non major bleeding events after 60 days [ Time Frame: After 60 days ]

Secondary Outcome Measures:
  • Composite number of all recurrent venous thromboembolisms and asymptomatic deterioration after 31 days [ Time Frame: After 31 days ]
  • Composite number of all recurrent venous thromboembolisms after 60 days [ Time Frame: After 60 days ]
  • Prothrombin time [ Time Frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 15 h for oral suspension and 22 h for tablet) ]
  • Activated partial thromboplastin time [ Time Frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 15 h for oral suspension and 22 h for tablet) ]
  • Anti-factor Xa activity [ Time Frame: 3x at day 15 (at 0h, 3h, 7h) and 1x at day 31 (at 15 h for oral suspension and 22 h for tablet) ]

Enrollment: 64
Study Start Date: February 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban
Rivaroxaban will be provided according to an age- and body weight-adjusted dosing schedule to achieve a similar exposure in children as that observed in adults treated for VTE (venous thromboembolism) with 20 mg rivaroxaban daily. Rivaroxaban will be provided as a tablet for children 12 to 18 years. Once the age-and body weight-adjusted dosing regimen has been finally confirmed for the age group 6 to < 12 years, rivaroxaban will be provided as tablets (and subsequently as oral suspension) for this age group.
Drug: Rivaroxaban (Xarelto, BAY59-7939)


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 6 to < 18 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 and alanine aminotransferase (ALT) and total bilirubin evaluated within 10 days prior to randomization
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01684423

  Show 59 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01684423     History of Changes
Other Study ID Numbers: 14373
2011-004539-30 ( EudraCT Number )
Study First Received: September 11, 2012
Last Updated: October 13, 2016

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on May 25, 2017