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EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis (EINSTEINJr)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02309411
First Posted: December 5, 2014
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
  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.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Young Children With Various Manifestations of Venous Thrombosis

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of major bleeding and clinically relevant non-major bleeding [ Time Frame: During or within 2 days after stop of study treatment ]

Secondary Outcome Measures:
  • Incidence of recurrent symptomatic venous thromboembolisms [ Time Frame: At 31 days ]
  • Prothrombin time [ Time Frame: Day1 (post dose at 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16h) ]
  • Activated partial thromboplastin time [ Time Frame: Day1 (post dose at 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16h) ]
  • Anti-factor Xa activity [ Time Frame: Day1 (post dose at 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16h) ]
    The anti-factor Xa assay is designed to measure plasma heparin,low molecular weight heparin and other anticoagulants

  • Incidence of asymptomatic deterioration in the thrombotic burden on repeat imaging [ Time Frame: At 31 days ]
  • Concentration of Rivaroxaban in blood as a measure of Pharmacokinetics [ Time Frame: Day1 (post dose at.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16h) ]

Enrollment: 47
Actual Study Start Date: January 15, 2015
Study Completion Date: April 5, 2017
Primary Completion Date: April 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban
Age and body weight-adjusted twice daily dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban once daily
Drug: Rivaroxaban(Xarelto,BAY59-7939)
With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 m2
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309411


  Show 87 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02309411     History of Changes
Other Study ID Numbers: 14374
2014-000566-22 ( EudraCT Number )
First Submitted: November 24, 2014
First Posted: December 5, 2014
Last Update Posted: June 5, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Pediatric

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants