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

NCT02309411 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-08-21

Study results available
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Summary

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.

Conditions

  • Venous Thromboembolism

Interventions

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-15
Primary Completion
2017-04-05
Completion
2017-04-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • Hungary
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02309411 on ClinicalTrials.gov